Interferon β-1b.
IFN β-1b (250 mcg subcutaneously every other day for two consecutive weeks) plus national protocol medications.
National protocol medications only.
National protocol medications (lopinavir/ritonavir (400/100 mg BD) or atazanavir/ritonavir (300/100 mg daily) plus hydroxychloroquine (400 mg BD in first day and then 200 mg BD) for 7-10 days).
Both groups received national protocol medications. The national protocol consisted lopinavir/ritonavir (400/100 mg BD) or atazanavir/ritonavir (300/100 mg daily) plus hydroxychloroquine (400 mg BD in first day and then 200 mg BD) for 7–10 days. Other supportive cares such as fluid therapy, stress ulcer prophylaxis, deep vein thrombosis, treatment of electrolyte disorders and antibiotic therapy were considered according to the hospital protocols.
COVID-19 severe or critically
Adult patients (≥18 years old) with positive PCR and clinical symptoms/signs of pneumonia (including dyspnea, cough and fever),peripheral oxygen saturation (SPO2) ≤ 93% in ambient air or arterial oxygen partial pressure to fractional inspired oxygen (PaO2/ FiO2) < 300 or SPO2/FiO2 < 315 and lung involvement in chest imaging.
Open-label.
Single-center, Imam Khomeini Hospital Center in Tehran, Iran.
Clinical improvement was defined as improvement of at least two points from the baseline status on the six-category ordinal scale. This scale contains the subsequent categories: (1) death (2) hospital admission requiring invasive mechanical ventilation (3) hospital admission, requiring non-invasive positive pressure ventilation (4) hospital admission, requiring oxygen (5) hospital admission, not requiring oxygen (6) discharge.
IFNβ1b
IFNβ1b subcutaneous injections of 8,000,000 IU on days 1, 3, 6 plus a single dose of hydroxychloroquine 400mg on the first day and Lopinavir/Ritonavir 400mg/100 mg twice a day for ten days.
Standard of care.
Hydroxychloroquine: single dose of 400 mg on day1, orally, and Lopinavir/Ritonavir (Kaletra): 400mg/100 mg twice a day for 10 days, orally.
Three arms: IFNβ1a, IFNβ1b, control group. All three groups received standards of care consisting of the necessary oxygen support, non-invasive, or invasive mechanical ventilation.
COVID-19 severe or critically
Male, non-lactating, and non-pregnant female patients with at least 18 years of age who had confirmed COVID-19, defined as a positive test of Reverse Transcriptase Polymerase-Chain Reaction (RT-PCR) with peripheral capillary oxygen saturation level (SpO2) ≤ 93% on pulse oximetry OR a respiratory frequency ≥ 24/minute while breathing ambient air] AND at least one in every of the following: contactless infrared forehead thermometer temperature of ≥ 37·8, muscle ache, rhinitis, headache, cough or fatigue onadmission AND acute onset time for the symptoms (Days ≤ 14).
Open-label.
Single center, Loghman Hakim Hospital, a leading academic hospital of Shahid Beheshti ,Tehran, Iran.
Seven-step ordinal scale: (I) Not hospitalized, and has no activity limitations; (II) Not hospitalized, but has activity limitations; (III) Hospitalized, but does not need any supplemental oxygen; (IV) Hospitalized, and needs supplemental oxygen; (V) Hospitalized, and needs either High-Flow Nasal Cannula (HFNC) or non-invasive ventilation;(VI) Hospitalized, and needs invasive ventilation; and (VII) Dead.
