meta|Evidence - COVID-19
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azithromycin (n=172) vs. standard of care (n=159)
randomized controlled trial some concerns about risk of bias
azithromycin plus hydroxychloroquine
standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days
hydroxychloroquine
standard care plus hydroxychloroquine at a dose of 400 mg twice dailyThe use of glucocorticoids, other immunomodulators, antibiotic agents others than macrolides , and antiviral agents was allowed
3 arms: hydroxychloroquine plus azythromycin, hydroxychloroquine monotherapy and standard of care
COVID-19 mild to moderate
open-label
Brazil, 55 sites
Randomization was performed in blocks of six and was stratified according to the use or nonuse of supplemental oxygen at the time of randomization
azithromycin (n=107) vs. standard of care (n=99)
randomized controlled trial some concerns about risk of bias
azithromycin
azithromycin 500 mg/24 h for 7 days
standard of care
3 arms azithromycin, clarithromycin or standard of care
COVID-19 mild to moderate
open-label
1 centre, Egypt
azithromycin plus hydroxychloroquine (n=217) vs. standard of care (n=227)
randomized controlled trial some concerns about risk of bias
Hydroxychloroquine plus azithromycin
Standard of care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days.
Standard of care
The use of glucocorticoids, other immunomodulators, antibiotic agents, and antiviral agents was allowed.
3 arms: hydroxychloroquine plus azythromycin, hydroxychloroquine monotherapy and standard of care (1:1:1 ratio). All patients received standard of care.
COVID-19 mild to moderate
Adult patients (18 years and older) with suspected or confirmed COVID-19 admitted to inpatients units and intensive care units. Patients using non-invasive ventilation or invasive mechanical ventilation were excluded. Patients with previous use of chloroquine, hydroxychloroquine, azithromycin or any other macrolide for more than 24h before enrollment were excluded.
Open-label.
Multicenter; 55 sites in Brazil.
Scores on the scale were defined as follows: a score of 1 indicated not hospitalized with no limitations on activities; 2, not hospitalized but with limitations on activities; 3, hospitalized and not receiving supplemental oxygen; 4,hospitalized and receiving supplemental oxygen;5, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 6, hospitalized and receiving mechanical ventilation; and 7, death.
3 interim analyses planned, only the first one was conducted.
azvudine (n=10) vs. antiviral and associated therapy (n=10)
randomized controlled trial some concerns about risk of bias
Azvudine
Oral azvudine tablets 5 mg/day (five tablets once a night) and symptomatic treatment.
Standard antiviral
interferon alpha, kaletra and ribavirin, chloroquine phosphate, and hydroxychloroquine sulfate
When patients developed clinical symptoms and signs, such as fever and cough, patients in both groups were treated with febrifuge or cough mixture, which was called symptomatic treatment.
COVID-19 mild to moderate
Confirmed COVID-19 by RT-PCR. The definition of mild COVID-19 was patients with mild clinical symptoms and without signs of pneumonia in imaging; the definition of commonCOVID-19 was patients with fever, respiratory, or other related symptoms, and with signs of pneumonia in imaging. Patients with one of the following conditions: respiratory failure and the need for mechanical ventilation; shock; intensive care unit (ICU) monitoring and treatment for other organ failures were excluded.
Open-label
Single center, Guangshan County People’s Hospital, China.
bromhexine (n=12) vs. standard of care (n=6)
randomized controlled trial some concerns about risk of bias
Bromhexine hydrochloride
Patients in the treatment group received BRH tablets (32 mg t.i.d.) three times per day after meals for 14 consecutive days. Treatment was discontinued once the patient met the discharge criteria.
Standard of care
Antiviral drugs, including arbidol hydrochloride granules (0.1 g–0.2 g t.i.d.) and recombinant human interferon α 2b spray (0.083 mL t.i.d.)
All patients were divided into the treatment group (BRH group) or the control group (control group) at a 2:1 ratio. All participants were treated with antiviral drugs, including arbidol hydrochloride granules (0.1 g–0.2 g t.i.d.) and recombinant human interferon α 2b spray (0.083 mL t.i.d.), on the doctors’ discretion according to China’s Novel Coronavirus Pneumonia Diagnosis and Treatment Plan.
COVID-19 mild to moderate
Hospitalized patients with COVID-19 (≥ 18 years but ≤ 80 years) with confirmed or clinically suspected mild or moderatecoronavirus pneumonia (COVID-19), based on China’s Novel Coronavirus Pneumonia Diagnosis and Treatment Plan.
Open-label.
Single center, The Second Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.
Clinical recovery was defined as clinical symptoms (fever and respiratory symptoms) returning to normal over 48 hours. Disease deterioration was defined as the presence of respiratory distress, respiratory rate ≥ 30 times/minute, oxygen saturation ≤ 93% in the resting state, and oxygenation index ≤ 300 mmHg.
chloroquine (n=-9) vs. placebo (n=-9)
randomized controlled trial risk of bias NA
chloroquine
450 mg x2 day 1, then 450 mg/d for 4 days
placebo
COVID-19 mild to moderate
double-blind
1 center, Brazil
found in Axfors et al meta-analysis
Ensitrelvir (XOCOVA) (n=-9) vs. placebo (n=-9)
randomized controlled trial some concerns about risk of bias
ensitrelvir 125 mg or 250 mg
loading dose of ensitrelvir on day1 (375 mg for the 125 mg group and 750 mg for the 250 mg group), followed by the maintenance dose (125 mg for the 125 mg group and 250 mg for the 250 mg group) on days 2 through 5 without dose modification
placebo
COVID-19 mild to moderate
A majority of the patients in the ITT population had been vaccinated (ensitrelvir 125 mg, 14 [87.5%]; ensitrelvir 250 mg, 12 [85.7%]; and placebo, 123 12 [70.6%])
double blind
japan, 56 centers
favipiravir (n=193) vs. lopinavir/ritonavir (n=187)
randomized controlled trial some concerns about risk of bias
favipiravir
Favipiravir 1600 mg stat and then 600 mg every 8 h plus hydroxychloroquine 200 mg twice a day for 1 week.
lopinavir/ritonavir
single dose of hydroxychloroquine 400 mg followed by 100 400 Lopinavir/Ritonavir twice a day for 1 week
Later on, during the trial (31 May 2020), in light of emerging evidence, daily hydroxychloroquine in the Favipiravir group was reduced to a single dose of 400 mg as in control group
COVID-19 mild to moderate
open-label
20 centres, Iran
favipiravir (n=175) vs. placebo (n=178)
randomized controlled trial high risk of bias
favipiravir
1,800 mg BID on Day 1 800 mg BID for next 9 days (maximum)
placebo
COVID-19 mild to moderate
double blind
20 centres, Kuwait
favipiravir (n=107) vs. placebo (n=49)
randomized controlled trial some concerns about risk of bias
Favipiravir
1800 mg twice a day on Day 1, followed by 800 mg twice a day for up to 13 days.
placebo
1:2 ratio. Seven patients in the placebo group were switched to treatment with favipiravir during Days 2–8 due to a lack of efficacy.
COVID-19 mild to moderate
Single blind.
Japan
Improvement was defined as follows:(1) improvement in temperature was defined as axillary temperature falling to =< 37.4 C and remaining at =< 37.4 C for at least 24 h (temperature recordings taken within 4 h after use ofan antipyretic were excluded); (2) improvement in SpO2 was defined as SpO2 remaining >= 96%for at least 24 h without the use of oxygen therapy; (3) improvement on chest imaging was defined as improvement in chest imaging findings taken at least 24 h after the previous image judged to be the worst; and (4) recovery to SARS-CoV-2-negative was defined as two consecutive negative results on qualitative tests by nucleic acid amplification separated by at least 24 h.
favipiravir (n=75) vs. placebo (n=74)
randomized controlled trial risk of bias NA
Favipiravir
Favipiravir administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
placebo
COVID-19 mild to moderate
double blind
USA
favipiravir (n=125) vs. standard of care (n=129)
randomized controlled trial some concerns about risk of bias
Favipiravir and Hydroxychloroquine
Favipiravir: 1800 mg twice daily for one day, followed by 800mg (total days of therapy is 10 days or till hospital discharge)Hydroxychloroquine (400mg) twice daily on day 1; for days 2-5 (200mg) twice daily.
standard of care
COVID-19 mild to moderate
open label
9 centers, Saudi Arabia
Moderate or Severe confirmed COVID-19
Trial stopped for futility after the first interim analysis
favipiravir (n=50) vs. standard of care (n=50)
randomized controlled trial some concerns about risk of bias
favipiravir
3200 mg (1600 mg 12 hourly) loading dose on day-1 followed by 1200 mg maintenance dose (600 mg 12 hourly daily) on day-2 to day-10
standard of care
oseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to day-5-10
COVID-19 mild to moderate
open label, randomized
2 centres, Egypt
favipiravir (n=75) vs. standard of care (n=75)
randomized controlled trial some concerns about risk of bias
favipiravir
3,600 mg (1,800 mg BID) (Day 1) 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days
sandard of care
Drugs thought to have antiviral activity against SARS CoV2 (including hydroxychloroquine) were prohibited
COVID-19 mild to moderate
open label
12 centres, India
Clinical cure was based on clinician assessment and defined as recovery of fever (axillary temperature ≤97.8°F), respiratory rate of ≤20 breaths/minute, oxygen saturation ≥98% without oxygen supplementation (which was later revised to align with the discharge criterion of ≥95% oxygen saturation issued by the Indian Ministry of Health prior to the start of the study), and cough relief (mild or no cough) maintained for ≥72 hours.
favipiravir (n=20) vs. standard of care (n=20)
randomized controlled trial some concerns about risk of bias
favipiravir
Favipiravir 1600 mg twice a day (BID) on Day 1 followed by 600 mg BID on Days 2-14 (1600/600 mg), or Favipiravir 1800 mg BID on Day 1 followed by 800 mg BID on Days 2-14 (1800/800 mg)
standard of care
COVID-19 mild to moderate
open label
6 centres, Russia
adaptative phase II/III3 arms : favipiravir low dose, or favipiravir high dose or SOC
favipiravir (n=100) vs. standard of care (n=100)
randomized controlled trial some concerns about risk of bias
favipiravir
1600 mg 2 times a day; on days 2-14 of treatment - 600 mg 2 times a day
standard of care
COVID-19 mild to moderate
open label
5 centres, Russia
Rate of clinical status improvement by categorical ordinal scale of clinical status improvement by 2 or more categories by Day 10 WHO Ordinal Scale for Clinical Improvement (WHO-OSCI), 0 - uninfected (There are no clinical and virological signs of infection), 8 - dead, higher scores mean a worse outcome
Article published in Russian. Results extracted from clinicaltrials.gov.
favipiravir (n=112) vs. standard of care (n=56)
randomized controlled trial some concerns about risk of bias
favipiravir
1800 mg BID on day 1, followed by 800 mg BID for up to9 days)
standard of care
umifenovir intranasal interferon alpha-2b, orhydroxychloroquine) for up to 10 days
COVID-19 mild to moderate
open label
10 centres, Russia
favipiravir plus interferon (n=44) vs. standard of care (n=45)
randomized controlled trial some concerns about risk of bias
favipiravir with interferon beta-1b by inhalation aerosol
favipiravir : 1600 mg (Day 1) followed by 600mg twice a day for a maximum of 10 daysinterferon beta-1 : 8million IU (0.25µg) twice a day for 5 days (through nebulization)
standard of care
HCQ 400 mg twice per day on the day 1, then 200 mg twice per day for 7 days
COVID-19 mild to moderate
open label
1 center, Oman
200 patients needed; due to logistical and financial constraints, only a total of 89 COVID-19 patients were enrolled into the study
hydroxychloroquine (n=-9) vs. placebo (n=-9)
randomized controlled trial risk of bias NA
hydroxychloroquine
placebo
COVID-19 mild to moderate
double blind
international
found in Axfors et al meta-analysisTerminated (Rate of enrollment too slow to allow completion in a reasonable timeframe
hydroxychloroquine (n=221) vs. standard of care (n=227)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine at a dose of 400 mg twice daily
hydroxychloroquine [400mg 2x/day, 12/12h] for 7 days
standard of care
The use of glucocorticoids, other immunomodulators, antibiotic agents, and antiviral agents was allowed
3 arms: hydroxychloroquine plus azythromycin, hydroxychloroquine monotherapy and standard of care
COVID-19 mild to moderate
open-label
Brazil, 55 sites
Randomization was performed in blocks of six and was stratified according to the use or nonuse of supplemental oxygen at the time of randomization
hydroxychloroquine (n=360) vs. standard of care (n=180)
randomized controlled trial high risk of bias
Hydroxychloroquine
Standard of care plus hydroxychloroquine 400mg twice daily on day 1, then 200mg twice daily for the next 5 days.
Standard of care
SOC treatment comprised daily oral vitamin C (2 g), oral zinc (50 mg), oral vitamin D(alfacalcidol 1 µg), and oral acetaminophen (for body aches and fever).
2:1 ratio. All patients received standard of care.
COVID-19 mild to moderate
Adult patients (18-80) with mild COVID-19 (PCR confirmed infection) and hospitalized.
Open-label.
Single-center; Pak Emirates Military Hospital, Rawalpindi, Pakistan.
Progression of disease was defined by the development of fever >101°F for >72 hours, shortness of breath with minimal exertion, derangement of basic laboratory parameters (ALC < 1000 or raised CRP), or appearance of infiltrates on X-ray chest.
hydroxychloroquine (n=15) vs. standard of care (n=15)
randomized controlled trial high risk of bias
hydroxychloroquine 400mg
hydroxychloroquine 400mg per day for 5 days
standard of care
COVID-19 mild to moderate
open-label
China
paper in chinese
hydroxychloroquine (n=31) vs. standard of care (n=31)
randomized controlled trial high risk of bias
hydroxychloroquine 400mg
additional oral HCQ (hydroxychloroquine sulfate tablets, Shanghai Pharma) 400 mg/d (200 mg/bid) between days 1 and 5
standard of care
COVID-19 mild to moderate
(RT-PCR) positive of SARS-coV-2; chest CT with pneumonia; saO2/SPO2 ratio > 93% or paO2/FIO2 ratio > 300 mmhg under room air
open-label
China, single center
there is some changes in the publication compared to the registry record (open control in place of placebo, sample size and the primary endpoint changed that does rule out the possibility of a selective publication bias)
ivermectin (n=82) vs. control (n=82)
randomized controlled trial high risk of bias
ivermectin12mg once daily for 3 days
standard protocol of treatment alone for 14 days
COVID-19 mild to moderate
patients from ages 20 to 65 with mildly to moderately affected COVID-19 infection confirmed by pharyngeal swab PCR
open-label
two tertiary hospitals in Egypt
ivermectin (n=21) vs. lopinavir/ritonavir (n=20)
randomized controlled trial high risk of bias
Ivermectin 6mg (given every 84 hours) twice a week, or Ivermectin 12mg (given every 84 hours) for 2 weeks,
lopinavir / ritonavir daily for 2 weeks
COVID-19 mild to moderate
double-bind
proof of concept study
ivermectin (n=48) vs. placebo (n=24)
randomized controlled trial high risk of bias
ivermectin alone or in combination with doxycycline
oral ivermectin alone (12 mg once daily for 5 days) or in combination with doxycycline (12 mg ivermectin single dose and 200 mg stat doxycycline day-1 followed by 100 mg 12hrly for next 4 days)
placebo
COVID-19 mild to moderate
says as double blind
Dhaka, Bangladesh
ivermectin (n=12) vs. placebo (n=12)
randomized controlled trial low risk of bias
ivermectin
400 mcg/kg, single dose
placebo
COVID-19 mild to moderate
double bliind
1 center, Spain
ivermectin (n=57) vs. placebo (n=58)
randomized controlled trial some concerns about risk of bias
Ivermectin
ivermectin 12 mg on day 1 and day 2
Placebo
COVID-19 mild to moderate
All patients above the age of 18 admitted with a diagnosis of COVID -19 (on the basis of a positive RT PCR or Rapid Antigen Test report) at AIIMS, Patna, India with mild or moderate disease as defined by the ministry of health and family welfare guidelines and not meeting any of the exclusion criteria were considered eligible for the study. The exclusion criteria were: known allergy to or adverse drug reaction with Ivermectin; unwillingness or inability to provide consent to participate in the study; prior use of ivermectin during the course of this illness; pregnancy and lactation.
Double-blind.
Single center, tertiary care dedicated COVID-19 hospital in Bihar, India.
ivermectin (n=104) vs. placebo (n=52)
randomized controlled trial high risk of bias
Ivermectin 24mg and 12mg
Single oral administration of Ivermectin 12 mg (equivalent to 200 µg/kg) elixir or Ivermectin 24 mg (equivalent to 400 µg/kg) elixir. A 20 mL dose of final formulation consisted of ivermectin (12 or 24mg) in ethanol (40% v/v) sweetened with syrup base.
Placebo
3 arms: Ivermectin 24 mg (single dose), Ivermectin 12 mg (single dose), or placebo.
COVID-19 mild to moderate
Aged 18 years or above and diagnosed with non-severe COVID-19, i.e. room air saturation (SpO2) >90%, and with no hypotension or requirement of mechanical ventilation. Diagnosis of COVID-19 was based on a positive result on either SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) or the rapid antigen test.
Double-blind.
Single center, India.
ivermectin (n=25) vs. standard of care (n=25)
randomized controlled trial high risk of bias
ivermectin
12mg stat and then 12 mg after 12 hours and 12mg after 24 hours
standard of care
COVID-19 mild to moderate
open label
1 center, Pakistan
ivermectin (n=50) vs. standard of care (n=50)
randomized controlled trial high risk of bias
ivermectin (single dose of 12 milligrams)
standard of care
COVID-19 mild to moderate
open-label
one hospital in Lahore, Pakistan
ivermectin (n=30) vs. standard of care (n=15)
randomized controlled trial some concerns about risk of bias
Ivermectin
Standard of care plus oral ivermectin at 0.6 mg/kg/day for 5 days.
Standard of care
All patients in both groups received standard of care.
COVID-19 mild to moderate
Eligibility criteria included COVID-19 symptoms onset ≤ 5 days at recruitment, absence of use of drugs with potentialactivity against SARS-CoV-2 and available in Argentina during the trial (hydroxychloroquine, chloroquine, lopinavir and azithromycin); and those drugs were not permitted during the first week of the trial.
Open-label.
4 hospitals in the metropolitan area of Buenos Aires, Argentina.
ivermectin (n=35) vs. standard of care (n=38)
randomized controlled trial some concerns about risk of bias
Ivermectin
Single dose of 0.2 mg/kg
Standard of care
Standard drugs of the national protocol are used.
All patients in both groups received supportive medical treatment for COVID-19 according to the national protocols of Iran at the time of this study (hydroxychloroquine and/or lopinavir/ritonavir).
COVID-19 mild to moderate
The diagnostic criteria for COVID-19 included any of the following: (1) positive result on COVID-19 reverse-transcription polymerase chain reaction; (2) clinical symptoms of COVID-19, with a history of contact with a patient with COVID-19; and/or (3) abnormalities on chest computed tomography (CT) compatible with COVID19 (ground-glass opacity, halo sign, reversed halo sign, and patchy infiltration).
Double-blind.
2 centers in Mazandaran, Iran.
Clinical improvement after baseline was defined as resolving a patient’s baseline status on persistent and continuous cough (persistent cough for >1 hour, or ≥3 coughing episodes in 24 hours, that interferes with activities of daily living and the ability to work) and tachypnea in addition to increasing oxygen saturation to >94%.
ivermectin (n=241) vs. standard of care (n=249)
randomized controlled trial some concerns about risk of bias
oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care
standard of care alone
symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging.
COVID-19 mild to moderate
open-label
Malaysia
ivermectin plus doxycycline (n=200) vs. standard of care (n=200)
randomized controlled trial some concerns about risk of bias
Ivermectin and Doxycycline
Ivermectin 6 mg, 2 tab stat and Doxycycline 100 mg twice daily for 5 days
standard of care
COVID-19 mild to moderate
double blind
1 center, Bangladesh
lopinavir/ritonavir (n=21) vs. standard of care (n=7)
randomized controlled trial some concerns about risk of bias
Lopinavir-ritonavir
Lopinavir (200mg) boosted by ritonavir (50mg) (oral, q12h, 500 mg each time for 7-14 days) monotherapy
Standard of care.
No antiviral medication. Supportive care and effective oxygen therapy if in need.
3 arms: lopinavir/ritonavir (n=21), arbidol=umifénovir (n=16) and standard of care (n=7).Standard of care in both groups.
COVID-19 mild to moderate
Open-label
China, single center
lopinavir/ritonavir, ribavirin and interferon beta-1b (n=86) vs. lopinavir/ritonavir (n=41)
randomized controlled trial some concerns about risk of bias
Interferon beta-1b, lopinavir–ritonavir, and ribavirin
14-day combination of lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin 400 mg every 12 h, and three doses of 8 million international units of interferon beta-1b on alternate days
lopinavir–ritonavir
14 days of lopinavir 400 mg and ritonavir 100 mg every 12 h
COVID-19 mild to moderate
age at least 18 years, a national early warning score 2 (NEWS2) of at least 1, and symptom duration of 14 days or less upon recruitment
Open-label.
Hong Kong, 6 centers
phase 2, intention-to-treat population
there is a discrepancy between the main objective of the study mentioned in clinicaltrials.gov which refers to mortality and the main endpoint presented in the publication. The sample size calculation also refers to mortality. However, at the date of initial registration (Feb. 19), the primary endpoint was already PCR-negative conversion, which allows to rule out result-driven change.
nitazoxanide (n=238) vs. placebo (n=237)
randomized controlled trial high risk of bias
Nitazoxanide
500 mg oral solution, 20 mg/mL (25 mL), three times daily ( 8/8hours) for 5 days.
Placebo
Placebo 8/8 hours for 5 days in the early clinical phase of COVID-19.
Placebo and nitazoxanide were color-matched.
COVID-19 mild to moderate
Consecutive adult patients (aged 18 years or older) who presented with clinical symptoms of Covid-19 (defined for the purposes of this trial as dry cough, fever, and/or fatigue) of no longer than 3 days’ duration were enrolled. Patients with negative reverse-transcriptase quantitative real-time polymerase chain reaction (RT-PCR) test for SARS-CoV-2 were excluded.
Double-blind.
2 hospitals in Brazil.
All patients took home a symptom journal designed to gather information on daily symptoms, new symptoms, and the date of resolution of each symptom
Nitazoxanide in the early clinical phase of COVID-19.
nitazoxanide (n=33) vs. placebo (n=13)
randomized controlled trial high risk of bias
Nitazoxanide
The protocol began with 1 g every 8 hours (3 g/day), but soon afterwards, it was changed to 500 mg (1 film-coated tablet) every 6 hours (2 g/day) plus standard of care.
Placebo
Placebo plus standard of care.
Patients were randomized 2:1 to receive nitazoxanide or placebo.
COVID-19 mild to moderate
people of both sexes aged = 18 years, with COVID-19, with a positive quantitative real-time polymerase reaction (rtq-PCR), no more than 4 days after the onset of symptoms. Patients with a chest Rx or lung ultrasound consistent with COVID-19 pneumonia were included if they had mild symptoms, defined as SpO2 = 95% when breathing room air and a RF < 24 per minute, or moderate symptoms, defined as SpO2 = 92% when breathing FiO2 through a low flow O2 cannula (< 5 l per minute).
Single-blind.
2 centers in Buenos Aires, Argentina.
Erradication will be considered a reduction of the viral load on day 7 greater than 35% with respect to placebo.
nitazoxanide (n=25) vs. placebo (n=25)
randomized controlled trial risk of bias NA
Nitazoxanide
NTZ 600 mg BID administered with food for 7 days
Placebo
Placebo BID administered with food for 7 days.
COVID-19 mild to moderate
Doubleblind.
6 hospitals in Sao Paulo, Brazil.
Phase II.
remdesivir (n=200) vs. remdesivir (n=197)
randomized controlled trial some concerns about risk of bias
Remdesivir (5 days)
Intravenous remdesivir 200 mg on day 1, followed by 100 mg of remdesivir once daily for the subsequent 4 days.
Remdesivir (10 days)
Intravenous remdesivir 200 mg on day 1, followed by 100 mg of remdesivir once daily for the subsequent 9 days.
Both treatment groups continued supportive therapy at the discretion of the investigator throughout the duration of the trial.
COVID-19 mild to moderate
Patients who were receiving mechanical ventilation and extracorporeal membrane oxygenation (ECMO) at screening were excluded, as were patients with signs of multiorgan failure.
Open-label.
55 hospitals in the United States, Italy, Spain, Germany, Hong Kong, Singapore, South Korea, Taiwan.
7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, receiving invasive mechanical ventilation or ECMO; 3, hospitalized, receiving noninvasive ventilation or high-flow oxygen devices; 4, hospitalized, requiring low-flow supplementaloxygen; 5, hospitalized, not requiring supplemental oxygen but receiving ongoing medical care (related or not related to Covid-19); 6, hospitalized, requiring neither supplemental oxygen nor ongoing medical care (other than that specified in the protocol for remdesivir administration); and 7, not hospitalized.
remdesivir (n=197) vs. standard of care (n=200)
randomized controlled trial some concerns about risk of bias
Remdesivir (10 days)
200 mg of remdesivir intravenously on day 1, followed by 100 mg of remdesivir once daily for the 9 subsequent days, infused over 30 to 60 minutes.
Standard of care
Treatment with SOC according to local practice.
3 arms study : RDV 5 days, RDV 10 days, standard of care. All participants will continue to receive SOC therapy according to local guidelines. Participants randomized to receive RDV will receive thisin addition to their other care. Remdesivir treatment was to be discontinued in any patient experiencing severe elevations in liver enzymes or decreases in estimated creatinine clearance to less than 30 mL/min.
COVID-19 mild to moderate
Participants with COVID-19 confirmed by polymerase chain reaction (PCR) who meet the following criteria: Willing and able to provide written informed consent (age ≥18) or assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures, Hospitalized and requiring medical care for COVID-19, SpO2 > 94% on room air at screening, Radiographic evidence of pulmonary infiltrates.
Open-label.
Multicenter: 105 hospitals in the United States, Europe, and Asia.
7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation; 3, hospitalized, requiringnoninvasive ventilation or use of high-flow oxygen devices; 4, hospitalized, requiring low-flow supplemental oxygen; 5, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related or not to COVID-19); 6, hospitalized, not requiring supplemental oxygen orongoing medical care; and 7, not hospitalized. Differences between remdesivir treatment groups and standard care were calculated usingproportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicatesdifference in clinical status distribution toward category 7 for the remdesivir group vs thestandard care group.
remdesivir (n=199) vs. standard of care (n=200)
randomized controlled trial some concerns about risk of bias
5-day course of remdesivir
200 mg of remdesivir intravenously on day 1, followed by 100 mg of remdesivir once daily for the subsequent days, infused over 30 to 60 minutes.
Standard care
Treatment with SOC according to local practice.
3 arms study : RDV 5 days, RDV 10 days, standard of care. All participants will continue to receive SOC therapy according to local guidelines. Participants randomized to receive RDV will receive thisin addition to their other care. Remdesivir treatment was to be discontinued in any patient experiencing severe elevations in liver enzymes or decreases in estimated creatinine clearance to less than 30 mL/min.
COVID-19 mild to moderate
Participants with COVID-19 confirmed by polymerase chain reaction (PCR) who meet the following criteria: Willing and able to provide written informed consent (age ≥18) or assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures, Hospitalized and requiring medical care for COVID-19, SpO2 > 94% on room air at screening, Radiographic evidence of pulmonary infiltrates.
Open-label.
Multicenter: 105 hospitals in the United States, Europe, and Asia.
7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation; 3, hospitalized, requiringnoninvasive ventilation or use of high-flow oxygen devices; 4, hospitalized, requiring low-flow supplemental oxygen; 5, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related or not to COVID-19); 6, hospitalized, not requiring supplemental oxygen orongoing medical care; and 7, not hospitalized. Differences between remdesivir treatment groups and standard care were calculated usingproportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicatesdifference in clinical status distribution toward category 7 for the remdesivir group vs thestandard care group.
sofosbuvir and ledipasvir (n=45) vs. standard of care (n=45)
randomized controlled trial some concerns about risk of bias
Sofosbuvir/ledipasvir
SOF/LDP 400/90 mg daily for 10 days plus standard of care.
Standard of care
Standard of care alone.
In addition to the supportive care modalities, the standard of care according to the hospital protocol included hydroxychloroquine (HCQ 400 mg BD at first day then 200 mg BD for 7 days) plus atazanavir/ritonavir 300/100 mg daily for 7 days. Standard of care in both groups.
COVID-19 mild to moderate
Adult patients (≥18 years old) with highly suspected (according to the clinical signs/symptoms andimaging findings) or confirmed (a positive PCR of pharyngeal or nasopharyngeal samples) COVID-19 who were admitted to medical wards of the hospital, were included.
Open-label.
Single-center, Imam Khomeini Hospital Complex, Tehran, Iran.
Clinical response was defined as one order decline in disease category in the five category ordinal scale. The categories are: death (5), mechanical ventilation (4), non-invasive ventilation (3), oxygen mask or nasal cannula (2), discharge(1).
umifenovir (arbidol) (n=35) vs. lopinavir/ritonavir (n=34)
randomized controlled trial some concerns about risk of bias
Umifenovir
Arbidol (100mg) (oral, 200mg TID for 7-14 days)
Lopinavir/ritonavir
Lopinavir (200mg) boosted by ritonavir (50mg) (orally administed, twice daily, 500 mg, each time for 7-14 days).
3 arms : lopinavir/ritonavir; arbidol and standard care
COVID-19 mild to moderate
Open-label
China, single center
No deaths occurred.
umifenovir (arbidol) (n=15) vs. standard of care (n=15)
randomized controlled trial high risk of bias
Umifenovir
600mg/d: orally administered, 200 mg three times per day for 1–5 days
Standard of care
Antivirals, antibiotics, immunoglobulin, and corticosteroids.
Standard of care in both groups.
COVID-19 mild to moderate
Age: 18-60
Not specified.
Single center, City Clinical Hospital in Bishkek, Kyrgyzstan.
Blindness unclear.
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