meta|Evidence - COVID-19
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baricitinib (n=4148) vs. standard of care (n=4008)
randomized controlled trial some concerns about risk of bias
baricitinib 4 mg once daily
baricitinib 4 mg once daily by mouth for 10 days or until discharge if sooner
usual standard of care alone
COVID 19 all comers
open-label
camostat mesilate (n=139) vs. placebo (n=69)
randomized controlled trial some concerns about risk of bias
Camostat Mesilate
2x100 mg pills 3 times daily (every 8h) for 5 days.
placebo
2 pills 3 times daily for 5 days.
2:1 ratio. Some patients received remdesivir and/or dexamethasone as standard of care. All participants also received prophylactic or therapeutic anticoagulatory treatment.
COVID 19 all comers
documented COVID-19 infection as evidenced by positive PCR (or comparable clinical assay) for SARS-coV-2 ; less than 48 hours since time of hospital admission OR if hospital-acquired COVID-19 is suspected, less than 48 hrs since onset of symptoms
Double-blind
Denmark (8 sites), Sweden (1 site).
Phase IIa. The scale consisted of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring high-flow oxygen therapy or noninvasive ventilation;6, hospitalized, requiring invasive mechanical ventilation; and 7,death. After discharged, phone interviews were conducted up to day 30 to monitor treatment adherence and clinical status.
chloroquine (n=18) vs. standard of care (n=12)
randomized controlled trial high risk of bias
chloroquine
chloroquine phosphate group: First dose of chloroquine phosphate 1 g first day, then 0.5g × 9 days
standard of care
according to the Chinese Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (5th Edition)
3 arms chloroquine, hydroxychloroquine and SoC
COVID 19 all comers
open-label
China, single center
Study planned to recruit 100 subjects with confirmed mild/moderate types ofCOVID-19. Study discontinuated after enrolling only 67 subjects with mild/moderate COVID-19Publication report only data on 48 patients with moderate type of COVID-19
convalescent plasma treatment (n=4) vs. standard of care (n=8)
randomized controlled trial low risk of bias
Convalescent plasma
Standard of care
COVID 19 all comers
Open-label.
Italy.
Study not published yet. Results and risk of bias assessment were extracted from Axfors C. et al meta-analysis https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06829-7?s=09.
darunavir cobicistat (n=15) vs. standard of care (n=15)
randomized controlled trial high risk of bias
Darunavir and cobicistat
1 pill of darunavir/cobicistat (a single-tablet regimen containing 800 mg of darunavir and 150 mg of cobicistat) per day for 5 days.
Conventional treatments
Patients did not receive oral antiviral drugs.
All the participants received interferon alpha 2b and standard of care as per guideline recommendation in China.
COVID 19 all comers
Diagnosed as pneumonia caused by 2019-ncoV, according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection made by national health commission of the people's republic of China.
Open-label.
Single-center, Shanghai Public Health Clinical Center, China.
After randomization, respiratory samples were collected every 1–2 days until viral clearance. Viral clearance was defined as reverse transcriptase polymerase chain reaction (RT-PCR) negative on at least 2 consecutive oropharyngeal swabs collected at least 1–2 days apart.
Pilot study.
favipiravir (n=44) vs. favipiravir (n=45)
randomized controlled trial high risk of bias
immediate favipiravir
favipiravir administered orally between day 1 and day 10, 1800 mg twice a day on day 1 followed by 800 mg twice a day from day 2
delayed favipiravir
favipiravir administered orally between day 6 and day 15, 1800 mg twice a day on day 6 followed by 800 mg twice a day from day 7
COVID 19 all comers
asymptomatic and minimally symptomatic patientsRT-PCR test positive
open label
25 centres, japan
favipiravir (n=10) vs. standard of care (n=10)
randomized controlled trial some concerns about risk of bias
favipiravir
The first dose was 1600 mg or 2200mg orally, followed by 600 mg each time, three times a day, and the duration of administration was not more than 14 days
standard treatment
antiviral treatment included lopinavir/ritonavir (400 mg/100 mg, bid, po.) or darunavir/cobicistat (800 mg/150 mg, qd, po.) and arbidol (200 mg, tid, po.
3 arms: favipiravir (n=10), baloxavir marboxil (n=10), current antiviral treatment (n=10)
COVID 19 all comers
exclusion of considered as severe disease: has an ongoing respiratory deficiency and subjected to invasive mechanical ventilation; or presence of shock; or admitted to the ICU due to complications;
open-label, randomized
1 center, China
Time to clinical improvement was defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven category ordinal scale or live discharge from the hospital, whichever came first.
favipiravir (n=-9) vs. tocilizumab (n=-9)
randomized controlled trial some concerns about risk of bias
favipavir
Favipiravir: On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day
tocilizumab
1 dose 4-8 mg/kg (max 400mg). 2nd dose within 24h if persistent fever
COVID 19 all comers
open label
10 centres, China
3 arms : Favipiravir Combined With Tocilizumab ; Favipiravir; Tocilizumab
favipiravir (n=120) vs. umifenovir (arbidol) (n=120)
randomized controlled trial some concerns about risk of bias
favipiravir
favipiravir tablets (1600 mg/time on the first day, twice a day; 600 mg/time from the second day to the end of the experiment, twice a day)
umifenovir
umifenovir (200 mg each time, 3 times a day, from the first day to the end of the trial)
COVID 19 all comers
double-blind
China, 3 hospitals
Clinical recovery was defined as continuous (>72 hours) recovery of body temperature, respiratory rate, oxygen saturation and cough relief after treatment
Some incorrectness in the paper (for example in the result table (table 2), it is not the rate ratio that is reported but the risk difference). Arise some concern about a selective reporting.
hydroxychloroquine (n=18) vs. standard of care (n=12)
randomized controlled trial high risk of bias
hydroxychloroquine
Hydroxychloroquine sulfate group 0.2 g BID × 10 days
standard of care
according to the Chinese Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (5th Edition)
COVID 19 all comers
open-label
China, single center
Study planned to recruit 100 subjects with confirmed mild/moderate types ofCOVID-19. Study discontinuated after enrolling only 67 subjects with mild/moderate COVID-19Publication report only data on 48 patients with moderate type of COVID-19
leflunomide (n=26) vs. interferon (n=24)
randomized controlled trial some concerns about risk of bias
Leflunomide
leflunomide (50 mgevery 12 hours, 3 consecutive times, orally; then 20 mg onc edaily for 8 days; a total course of 10 days) plus nebulized interferon alpha 2a (IFN-α-2a; 3 million IU each time, adding2 mL of sterilized water, atomization inhalation twice daily for10 days)
Interferon alpha 2a
IFN-α-2a, 3 million IU each time, twice daily for 10 days.
COVID 19 all comers
(1) age 18–70 years with a diagnosis of COVID-19 conforming to Chinese guidelines (2) hospitalized for prolonged postsymptomatic viral shedding; (3) able to orally take medication; (4) if female, not pregnant; and (5) effective contraception for 7 days after taking the last medication.
Open-label.
Single center, Renmin Hospital of Wuhan University, Wuhan, China.
losartan (n=101) vs. placebo (n=104)
randomized controlled trial some concerns about risk of bias
losartan for 7 days or hospital discharge
Losartan 50 mg PO twice daily (100 mg daily total) administered for 10 days.
placebo for 7 days or hospital discharge
placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
COVID 19 all comers
18 years and older with presumptive positive laboratory test for SARS-coV-2 or upper respiratory infection with recent exposure to laboratory-proven SARS-coV-2-infected person�negative influenza and respiratory virus panel�new or worsening hypoxia (spO2 <95%) compared to baseline or increasing oxygen requirement�randomization within 24 hours of initial presentation to a hospital (inclusive of transfer)exclusion criteria:�currently taking an angiotensin converting enzyme inhibitor (ACei) or angiotensin receptor blocker (ARB)�prior reaction or intolerance to an ARB or ACei
Double-blind.
Multi-center: 13 hospitals in the United States.
Participants discharged prior to day 7 were provided a home pulse oximeter and contacted via phone.
nirmatrelvir / ritonavir (Paxlovid) (n=1140) vs. placebo (n=-9)
randomized controlled trial risk of bias NA
paxlovid
placebo
COVID 19 all comers
double blind
interim results from pfizer press release https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-additional-phase-23-study-results
remdesivir (n=43) vs. standard of care (n=58)
randomized controlled trial some concerns about risk of bias
Remdesivir
Standard of care plus 200 mg of intravenous remdesivir on day 1, then 100 mg daily up to 9 days. All study treatments were discontinued at discharge.
Standard care
Local SoC.
3 arms: hydroxychloroquine, remdesivir and standard of care. During the study, local SoC changed as the RECOVERY trial and updated WHO guidelines recommending systemic steroids for severe and critical COVID-19.
COVID 19 all comers
Adult patients (≥18 years) with SARS-CoV-2 infection confirmed by PCR who were admitted to the hospital ward or intensive care unit (ICU) with no anticipated transfer to a nonstudy hospital within 72 hours of inclusion. Informed consent by the study participant or legally authorized representative was provided before inclusion.
Open-label.
23 hospitals in Norway.
From 8 June 2020 on, NOR-Solidarity allocated patients only to SoC and remdesivir (hydroxychloroquine removed because of lack of evidence of its effectiveness).
Add-on Solidarity trial.
remdesivir (n=43) vs. standard of care (n=58)
randomized controlled trial low risk of bias
Remdesivir
Standard of care plus intravenous remdesivir 400 mg on day 1, then 200 mg daily up to 9 days.
Standard of care
Local SoC.
3 arms: remdesivir, hydroxychloroquine, standard of care. All study treatments were stopped at discharge. During the course of the study, local SoC changed as a result of the RECOVERY trial and updated WHO guidelines recommending systemic steroids for severe and critical COVID-19 (September 4th 2020).
COVID 19 all comers
adult patients (≥18 years), with confirmed SARS-2-CoV-2 infection by PCR, admitted to the hospital ward or the intensive care unit (ICU), with no anticipated transfer to a non-study hospital within 72 hours of inclusion. Informed consent by the study subject or legally authorized representative was provided prior to inclusion.
Open-label.
23 hospitals in Norway.
tocilizumab (n=161) vs. placebo (n=81)
randomized controlled trial low risk of bias
Tocilizumab
Tocilizumab single dose (8 mg per kilogram of body weight administered intravenously, not to exceed 800 mg) plus standard of care.
Placebo
COVID 19 all comers
Age > 18 and < 80 years old, Male or female gender, Confirmed SARS-CoV-2 infection by NP swab PCR, Admitted to non-ICU level care at MGH WITH evidence of severe COVID-19 (at least 2 of the following): Fever > 38C, Pulmonary infiltrates on chest X ray, Need for supplemental O2 to maintain saturation > 92% AND at least 1 of the following: Ferritin > 500 ng/ml, CRP > 50 mg/L, LDH >250 U/L, D-dimer > 1000 ng/mL.
Double-blind.
7 Boston hospitals, United States.
tocilizumab (n=136) vs. standard of care (n=134)
randomized controlled trial risk of bias NA
experimental: intervention early administration of tocilizumab associated with hydroxychloroquine and azithromycin
tocilizumab 162 mg sc x 2 doses tocilizumab 162mg sc x 2 doses at 12 hours (day 1)hydroxychloroquine 400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)azithromycin 500 mg / day v.o. for 3 days
hydroxychloroquine and azithromycin
hydroxychloroquine 400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)azithromycin 500 mg / day v.o. for 3 days
COVID 19 all comers
open-label
Spain
pilot, randomized, multicenter, open-label clinical trial
umifenovir (arbidol) (n=16) vs. standard of care (n=7)
randomized controlled trial some concerns about risk of bias
arbidol
arbidol (100mg) (oral, 200mg TID for 7-14 days)
standard care
3 arms : lopinavir/ritonavir; arbidol and standard care
COVID 19 all comers
open-label
China, single center
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