meta|Evidence - COVID-19
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anakinra (n=59) vs. control (n=57)
randomized controlled trial some concerns about risk of bias
usual care plus anakinra (200 mg twice a day on days 1–3, 100 mg twice on day 4, 100 mg once on day 5)
usual care alone
COVID-19 mild to moderate
patients with mild-to-moderate COVID-19 pneumonia, severe acute respiratory syndrome coronavirus 2 infection confirmed by real-time RT-PCR, requiring at least 3 L/min of oxygen by mask or nasal cannula but without ventilation assistance, a score of 5 on the WHO Clinical Progression Scale (WHO-CPS), and a C-reactive protein serum concentration of more than 25 mg/L not requiring admission to the intensive care unit at admission to hospital
open-label
16 university hospitals in France
casirivimab/imdevimab (Ronapreve) (n=912) vs. placebo (n=452)
randomized controlled trial some concerns about risk of bias
REGEN-COV Casirivimab and imdevimab
2.4 g or 8.0 gREGEN-COV (1.2 g casirivimab and1.2 g imdevimab)
Placebo
Single intravenous dose.
3 arms ratio 1:1:1 : 2.4 g REGEN-COV (1.2 g casirivimab and1.2 g imdevimab), 8.0 g REGEN-COV (4.0 g casirivimab and 4.0 g imdevimab), or placebo as a single intravenous dose. Standard-of-care treatments for Covid-19, per the investigator, were permitted.
COVID-19 mild to moderate
Double-blind.
103 sites in the United States, Brazil, Chile, Mexico, Moldova, and Romania
Primary endpoints were tested hierarchically.
*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.* Trial was stopped earlier than planned (due to low enrollment prior to the surge associated with the Delta variant).
clarithromycine (n=99) vs. standard of care (n=99)
randomized controlled trial some concerns about risk of bias
clarithromycin
500mg /12 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
colchicine (n=52) vs. standard of care (n=51)
randomized controlled trial some concerns about risk of bias
Colchicine
Standard of care plus initial dose of 1.5 mg (1 mg and 0.5 mg two hours after) of colchicine, followed by 0.5 mg every 12 hours during the next 7 days and 0.5 mg every 24 hours until the completion of 28 days of total treatment.
Standard of care
Both colchicine and control group patients received the recommended standard treatment in the study: dexamethasone (6 mg once a day for 10 days) in patients who required supplemental oxygen (WHO scale ≥4). Remdesivir was administered for 5 days following the Spanish Agency of Medications and Pharmaceutical Products recommendation which included: time from symptoms onset <7 days; two or more measurements of oxygen saturation below 94% on room air, respiratory rate >24 breaths/min without supplemental oxygen or Pa02/Fi02<300 (Kirby index). Tocilizumab was administered at a single dose of 600 mg and baricitinib at 4 mg/day for 14 days. The need for tocilizumab or baricitinib was established according to the physician on care criteria.
COVID-19 mild to moderate
Exclusion of patient needing mechanical ventilation, non-invasive or invasive, or extracorporeal membrane oxygenation support (ECMO).
Open-label, randomized.
Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain.
multiple testing102 patients
convalescent plasma treatment (n=80) vs. placebo (n=80)
randomized controlled trial low risk of bias
Convalescent plasma
250 ml of convalescent plasma with an IgG titer greater than 1:1000 against SARS-CoV-2 spike (S) protein (COVIDAR IgG, Instituto Leloir, Argentina).
Placebo
250 ml of placebo (0.9% normal saline).
Convalescent plasma or placebo was administered less than 72 hours after the onset of symptoms, and the infusions were given over a period of 1.5 to 2.0 hours. None of the patients received any experimental therapy for Covid-19 besides convalescent plasma.
COVID-19 mild to moderate
Patients who were 75 years of age or older, irrespective of current coexisting conditions, or between 65 and 74 years of age with at least one coexisting condition were identified and assessed for eligibility. At the time of screening for SARS-CoV-2 by reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay, eligible patients had had at least one of each sign or symptom in the following two categories for less than 48 hours: a temperature of at least 37.5, unexplained sweating, or chills; and dry cough, dyspnea, fatigue, myalgia, anorexia, sore throat, dysgeusia, anosmia, or rhinorrhea.
Double-blind
Clinical sites and geriatric units in Argentina
The trial was stopped early at 76% of its projected sample size because cases of Covid-19 in the trial region decreased considerably and steady enrollment of trial patients became virtually impossible.
convalescent plasma treatment (n=235) vs. standard of care (n=229)
randomized controlled trial high risk of bias
Convalescent plasma
Two doses of 200 mL CP was transfused 24 hours apart plus best standard of care
Standard of care
Best standard of care only
SoC in both groups
COVID-19 mild to moderate
The trial was conducted in 39 hospitals across India, with some level of heterogeneity across the trial sites for best standard of care and participantenrolment.
Open-label.
39 public and private hospitals across India.
Phase 2.
imatinib (n=55) vs. lopinavir/ritonavir plus chloroquine (n=-9)
randomized controlled trial risk of bias NA
-lopinavir/ ritonavir hydroxychloroquine-imatinib hydroxychloroquine-baricitinib hydroxychloroquine
no formal control groupcomparison between 3 active treatment groups
3 arms study
COVID-19 mild to moderate
open-label
madrid, spain
prospective, phase II, randomized, open-label, 3 parallel groups study
no formal control groupcomparison between 3 active treatment groups
Indomethacin (n=103) vs. paracetamol (n=107)
randomized controlled trial some concerns about risk of bias
Indomethacin
Standard of care plus indomethacin 75mg (once a day for BMI<30, twice a day for BMI>30). A proton pump inhibitor was also added along with indomethacin.
Paracetamol
Standard of care plus paracetamol 650mg four times a day.
All patients in both groups received standard of care (doxycycline, ivermectin, vitamin C, zinc, cough syrup).
COVID-19 mild to moderate
Hospitalized adult patients (20-90), with positive RT-PCR, normal KFT, normal LFT, oxygen saturation 94% or more.
Open-label.
Panimalar Medical College, Chennai, India.
Follow-up through a telephonic enquiry.
interferon / TFF2 (n=40) vs. standard of care (n=40)
randomized controlled trial some concerns about risk of bias
Interferon kappa plus TFF2
Both proteins (5 mg TFF2 plus 2 mg IFN-k) were dissolved in 5 mL sterilized water, and the combination aerosol was delivered to the patient for 20 to 30 min by a nasal mask driven by a medical compressed air atomizer (YUWELL, 403M). The aerosol inhalation treatment started from the first day of hospitalization and was administered 6 times every 24 h.
Standard care
Standard care alone. Standard care included symptomatic treatment with hydroxychloroquine, antibiotic agents, vasopressors, antifever medicine, vitamin C, immune enhancers, or traditional Chinese medicines.
Both groups received standard of care.
COVID-19 mild to moderate
Male and nonpregnant femalepatients at 18 years of age or older were eligible after they were confirmedas SARS-CoV-2 positive by RT-PCR. In addition, patients wereincluded if their peripheral capillary oxygen saturation (SpO2) was >94% on room air at screening. Symptoms of infection include fever,cough, and myalgia, with diarrhea, with the subsequent developmentof dyspnea or of pneumonia on chest CT. Patients with moderatepneumonia were then included following Diagnosis and TreatmentProtocol for Novel Coronavirus Pneumonia
Open-label.
Single center, Shanghai Public Health Clinical Center, Shanghai, China.
lenzilumab (n=261) vs. placebo (n=259)
randomized controlled trial some concerns about risk of bias
Lenzilumab
Standard of care plus three intravenous doses of lenzilumab (600 mg per dose) delivered 8h apart. Infusions beginning at day 0 within 12h of randomisation.
Placebo
Standard of care plus three doses of 0.9% saline for injection delivered 8h apart.
All patients received standard supportive care, including the use of remdesivir and corticosteroids. Paracetamol 500–1000 mg orally or intravenously and diphenhydramine 12.5–25 mg intravenously or 25 mg orally (or equivalent) were administered approximately 1h before lenzilumab or placebo infusion to prevent hypersensitivity reactions.
COVID-19 mild to moderate
At least 18 years of age; experienced blood oxygen saturation (SpO2) of less than or equal to 94%; or required low-flow supplemental oxygen, or high-flow oxygen support, or non-invasive positive pressure ventilation (NIPPV); and were hospitalized but did not require IMV. Patients were excluded if they required IMV or extracorporeal membrane oxygenation (ECMO).
Double-blind.
29 sites in the US and Brazil.
For the purposes of the survival analysis for the primary endpoint, an event was defined as mortality or the requirement for IMV.
peginterferon (n=60) vs. placebo (n=60)
randomized controlled trial some concerns about risk of bias
Peginterferon Lambda-1a
Peginterferon Lambda-1a (180 mcg subcutaneous injection) single dose alone with standard of care.
Placebo
Normal saline placebo subcutaneous injection along with standard of care Treatment for COVID-19 Infection.
COVID-19 mild to moderate
Age ≥ 18 years and ≤ 75 years at the time of the assessmentAble and willing to understand the study, adhere to all study procedures, and provide written informed consentDiagnosis of COVID-19 disease:If symptomatic, the presence of mild to moderate symptoms without signs of respiratory distress, with FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 within 72 hours from swab to the time of commencing informed consent:If asymptomatic, initial diagnosis of SARS-CoV-2 infection with positive FDA-cleared molecular diagnostic assay obtained no more than 72 hours from initial swab to the time of commencing informed consent
Open-label.
Single-blind.
Phase II. Single-blind study in which only patients are blinded.
pegylated interferon-α2b (n=20) vs. standard of care (n=20)
randomized controlled trial some concerns about risk of bias
Single dose of PEG IFN-α2b
PEG IFN-α2b; 1 mg/kg subcutaneous injection, single dose, plus SOC.
Standard of care
SOC alone.
Antipyretics, cough suppressants, antibiotics, steroids, vitamins, anticoagulants, and hydroxychloroquine were administered as per regulatory recommendation and approval.
COVID-19 mild to moderate
1. Ability to comprehend and willingness to sign a written ICF for the study 2. Male or non-pregnant females, >= 18 years of age at the time of enrolment 3. Understands and agrees to comply with planned study procedures 4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen 6.Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).
Open-label.
Multicenter, six study centers in India.
The primary efficacy endpoint was clinical status assessed onday 15 on a WHO 7-point ordinal scale consisting of the following categories: 1, not hospitalized, no limitations of activities; 2, not hospitalized, limitation on activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, on non-invasive ventilation or high flow oxygen devices; 6, hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and 7, death.
Phase II. All patients were hospitalized.
pegylated interferon-α2b (n=120) vs. standard of care (n=130)
randomized controlled trial some concerns about risk of bias
Pegylated interferon-α2b
Standard of care plus a single dose of PEG IFN-α2b.
Standard of care
SOC treatments [i.e. antipyretics, cough suppressants, antibiotics, steroids, vitamins, anticoagulants, hydroxychloroquine and antivirals (e.g. remdesivir)] were administered as per the COVID-19 clinical management guidelines of the Ministry of Health, Government of India and the practices of the individual institutions.
COVID-19 mild to moderate
age ≥18 years, RT-PCR-confirmed SARS-CoV-2 infection, pneumonia with no signs of severe disease, respiratory rate ≥24 breaths/min, SpO2 90–94%, and a negative pregnancy test (for female patients of child-bearing potential).
Open-label.
Multicenter; 20 study centers across India.
The scale consists of the following categories: 1, not hospitalized, no limitation of activities; 2, not hospitalized, limitation of activities; 3, hospitalized, does not require supplemental oxygen; 4, hospitalized, requires supplemental oxygen; 5, hospitalized, requires noninvasive ventilation or on high flow oxygen devices; 6, hospitalized, requires invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and 7, death.
tofacitinib (n=50) vs. standard of care (n=50)
randomized controlled trial risk of bias NA
COVID-19 mild to moderate
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