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casirivimab/imdevimab (Ronapreve) (n=912) vs. placebo (n=452)
randomized controlled trial
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).
convalescent plasma treatment (n=80) vs. placebo (n=80)
randomized controlled trial
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.
interferon / TFF2 (n=40) vs. standard of care (n=40)
randomized controlled trial
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.
peginterferon (n=60) vs. placebo (n=60)
randomized controlled trial
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
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
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.
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