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recombinant super-compound interferon rSIFN-co (n=48) vs. IFN alpha (n=48)
randomized controlled trial
Nebulized rSIFN-co
12 IU, twice daily immediately after randomization until discharged from the hospital, but not more than 28 days.
Nebulized interferon-alpha
Interferon-alpha-2a or interferon-alpha-2b, 5 million IU, twice daily, immediately after randomization until discharged from thehospital, but not more than 28 days.
All patients received the standard care. The baseline antiviral agents were lopinavir-ritonavir (400mg and100 mg, orally, twice daily) or umifenovir (200 mg,orally, thrice daily).
COVID 19 hospitalized
1. Age over 18 years old; 2. Real-time fluorescent RT-PCR for respiratory or blood specimens to detect novel coronavirus nucleic acid positive; 3. The sequence of virus genes in respiratory or blood samples was highly homologous with the known novel coronavirus; 4. A common or severe type of new type of coronavirus pneumonia was diagnosed. The common patients diagnosed with novel coronavirus pneumonia that have fever, respiratory symptoms, and imaging shows pneumonia. Some severe patients could be included. Accord with any of the following: (1) Respiratory distress, RR >= 30 times / minute; (2) In resting state, means oxygen saturation <= 93%; (3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <=300mmHg.
Single-blind.
Multicenter, five hospitals in Wuhan city and Chengdu city, China.
Patients were blinded to treatment allocation, whereas treating physicians were aware of group allocations.
This trial was designed as an exploratory one and was not powered statistically to measure a specific outcome,thus sample size estimates were not based on statistical power assessments.
SNG001 inhaled interferon beta (n=50) vs. placebo (n=51)
randomized controlled trial
Interferon beta-1a (SNG001)
6 MIU interferon beta-1a (SNG001) for inhalation use via nebuliser, once daily for 14 days.
Placebo
Nebulisation solution for inhalation use, once daily for 14 days. Placebo had the same formulation as SNG001, excluding the active substance.
Local standard of care treatment in both groups. SNG001 and placebo were identical in appearance.
COVID 19 hospitalized
Adults aged 18 years or older, admitted to hospital with COVID-19 symptoms. Patients had to have a confirmed SARS-CoV-2test result in a UK National Health Service (NHS) diagnostic, qualitative RT-PCR assay or a positive point-of-care test (FebriDx, Lumos Diagnostics, Sarasota, FL,USA) within the previous 24 h.17 Patients unable to use a nebuliser with a mouthpiece (eg, ventilated patients and patients in intensive care); were ecluded.
Double-blind.
Multicentre, 9 specialist hospitals in United Kingdom.
Phase II pilot trial.The OSCI is a 9-point scale, where 0 corresponds to no infection and 8 corresponds to death.
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.
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.
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