Trial NCT04350684
Publication Alavi Darazam I (2), Int Immunopharmacol, 2021 (published paper)
Funding: No specific funding (none;
Funding: Not applicable.)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Iran Follow-up duration (days): 21 | |
| Inclusion criteria | Moderate to severe confirmed Covid-19 cases by RT-PCR and/or CT-scan; age > 18 years; Presence of at least one of the following manifestation: radiation contactless body temperature ≥ 37.5 °C, cough, shortness of breath, nasal congestion/discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue; Peripheral capillary oxygen saturation level (SpO2) ≤ 93% on pulse oximetry; A respiratory frequency ≥ 24/minute while breathing ambient air (on admission day); Acute onset of symptoms (≤14 days). |
| Exclusion criteria | Consumption of potentially interacting medications with lopinavir/ritonavir or IFN-β1a; pregnancy and breastfeeding; history of alcohol use disorder, or any illicit drug dependence within the past five years, blood AST/ALT levels ≥ 5-fold higher relative to maximum limit of normal range on laboratory findings; participation refusal; who needed invasive ventilation from the beginning. |
| Interventions | |
| Treatment
Lopinavir/ritonavir + hydroxychloroquine + interferon-Beta1a + umifenovir LPV/r 400/100 mg twice a day orally for 10-14 days + HCQ 400 mg orally once off + IFN-Beta-1a 44 mcg subcutaneously on days 1,3,5 + UMI 200 mg three times a day for 7 days |
|
| Control
Lopinavir/ritonavir + hydroxychloroquine + interferon Beta-1a ( / ) | |
| Participants | |
| Randomized 101 participants (n1=51 / n2= 50) | |
| Characteristics of participants N=101 Mean age : 61.2 57 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=101 Critical: n=0 | |
| Primary outcome | |
| In the register Time to clinical improvement [ Time Frame: From date of randomization until 14 days later. ] Improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first. | |
| In the report Improvement of two points of the seven-category ordinal scale or discharge from the hospital, whichever comes first. | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
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| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The trial was registered as a triple-blind, placebo-controlled RCT, but reported as an open-label RCT. The trial appears to have been registered prospectively on April 14 2020, with an estimated start date of April 15. No recruitment dates are reported. The estimated enrollment in the registry was 40, whereas the sample size calculations in the article required a sample size of 100, which was achieved. The time point for mortality as 14 days in the registry, but reported at 21 days. The laboratory outcomes reported in the article were not included in the registry. |