meta|Evidence - COVID-19
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IFN beta-1a (n=487) vs. placebo (n=482)
randomized controlled trial some concerns about risk of bias
Interferon beta-1a
44 mcg of interferon beta-1a administered by a 0.5 mL subcutaneous injection on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses. plus remdesivir.
Placebo
0.5 mL placebo injection administered subcutaneously on Days 1, 3, 5, and 7 while hospitalized for a total of 4 doses plus remdesivir.
All hospitalized patients also received intravenous remdesivir as a 200 mg loading dose on day 1 followed by a 100 mg maintenance dose administered daily for up to 9 days. All patients received standard supportive care by the trial site hospital,including glucocorticoids, but other experimental treatments for COVID-19 were prohibited.
COVID-19 severe or critically
Patients already on mechanical ventilation were excluded.
Double-blind.
63 hospitals across five countries (Japan, Mexico, Singapore, South Korea, USA).
Disease severity was defined according to the eight-category ordinal scale used in previous ACTT studies. Patients defined by a score of :1 were not hospitalised and had no limitations to theiractivities; 2 were not hospitalised but had limitations to their activities or required home oxygen supplementation,or both; 3 were hospitalised but did not require supplemental oxygen and no longer required ongoing medical care; 4 were hospitalised and did not require supplemental oxygen but did require ongoing medical care; 5 were hospitalised and required any supplemental oxygen;6 were hospitalised and required non-invasive ventilation or use of high-flow oxygen devices; 7 were hospitalised and receiving invasive mechanical ventilation or extracorporeal membrane oxygenation; and 8 were those who had died.
IFN beta-1a (n=46) vs. standard of care (n=46)
randomized controlled trial high risk of bias
Interferon beta-1a
IFN β-1a in addition to the standard of care. Each 44 micrograms/ml (12 million IU/ml) of interferon β-1a (ReciGen®, CinnaGen Co., Iran) was subcutaneously injected three times weekly for two consecutive weeks.
Standard of care
Hydroxychloroquine (400 mg BD in first day and then 200 mg BD) plus lopinavir/ritonavir (400/100 mg BD) or atazanavir/ritonavir (300/100 mg daily) for 7-10 days (hospital protocol).
Both groups received standard of care. Primary care, respiratory support, fluid, electrolytes, analgesic, antipyretic, corticosteroid and antibiotic were recommended in the hospital protocol if indicated.
COVID-19 severe or critically
Adult patients (aged ≥ 18 years old) with the severe disease with following criteria: (1) hypoxemia (need for noninvasive or invasive respiratory support to provide capillary oxygen saturation above 90%) (2) Hypotension (systolic blood pressure less than 90 mmHg or vasopressor requirement) (3) renal failure secondary to COVID-19 (according to KDIGO definition) (4) neurologic disorder secondary to COVID-19 (decrease of 2 or more scores in Glasgow Coma Scale) (5) thrombocytopenia secondary to COVID-19 (platelet count less than 150000 /mm3) (6) severe gastrointestinal symptoms secondary to COVID-19 (vomiting/diarrhea that caused at least mild dehydration). The diagnosis of COVID-19 was according to either a positive Real-Time Polymerase Chain Reaction (RT-PCR) of the respiratory tract samples or clinical signs/symptoms and imaging findings highly suspicious for COVID-19.
Open-label.
Single center, Imam Khomeini Hospital Complex, Tehran, Iran.
Clinical response was defined according to the six-category ordinal scale. The six categories are: (1) discharge (2) hospital admission, not requiring oxygen (3) hospital admission, requiring oxygen (4) hospital admission, requiring non-invasive positive pressure ventilation (5) hospital admission requiring invasive mechanical ventilation (6) death.
IFN beta-1a (n=20) vs. standard of care (n=20)
randomized controlled trial some concerns about risk of bias
IFNβ1a
IFNβ1a (Recigen) (Subcutaneous injections of 44μg (12,000 IU) ondays 1, 3, 6) plus a single dose of hydroxychloroquine 400mg and Lopinavir/Ritonavir 400mg/100 mg twice a day for 10 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) .
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.
IFN beta-1b (n=40) vs. standard of care (n=40)
randomized controlled trial some concerns about risk of bias
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.
IFN beta-1b (n=20) vs. standard of care (n=20)
randomized controlled trial some concerns about risk of bias
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.
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