Trial NCT04343768
Publication Darazam IA, COVIFERON, 2021 (Unblinded)
Dates: 4/9/2020 to 4/19/2020
Funding: No specific funding
Conflict of interest: No
| Methods | |
| RCT Blinding: preprint | |
| Location :
Single center / Iran (Islamic Republic of) Follow-up duration (days): 21 | |
| Inclusion criteria | Male, non-lactating, and non-pregnant female patients ; at least 18 years of age ; confirmed COVID-19, defined as a positive test of Reverse Transcriptase Polymerase-Chain Reaction (RT-PCR) ; confirmed COVID-19 compatible lung involvement were admitted - all patients included in the study, also had a positive Computed Tomography Scan (CT Scan) ; [having a 1peripheral 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 on admission] AND [acute onset time for the symptoms (Days ⤠14)]. |
| Exclusion criteria | Patients with cardiac arrhythmias (prolonged PR or QT intervals, third- or second-degree heart block) ; consumption of potentially interacting medications with Lopinavir/Ritonavir + HCQ, IFNβ1a, IFNβ1b ; history of alcohol use disorder, or any illicit drug dependence within the past five years ; blood AST/ALT levels ⥠5-fold the maximum limit of normal range on laboratory findings ; participation refusal. |
| Interventions | |
| Treatment 1 Interferon beta-1b | |
| Control Standard care | |
| Treatment 3 Interferon beta-1a | |
| Participants | |
| Randomized 60 participants n1=20/ n2=20/ n3=20 | |
| Characteristics of participants N=60 Mean age : NR 31 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* 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 (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first. | |
| In the report Our primary outcome measure was TTCI [time to clinical improvement], defined as the time from enrollment to discharge from the hospital or a decline of two steps on the 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 | |
| Documents avalaible |
Protocol Yes. In English Statistical plan NA Data-sharing stated Yes |
| 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 pre-print article, published protocol summary and prospective trial registry were used in data extraction and assessment of risk of bias. There were some differences in outcomes and endpoints between the pre-print article, the published protocol summary and trial registry, although overall the study was reported as planned. The study achieved its pre-stated sample size. Altough the study is reported as 'open-label' it is stated that outcomce assessors were blinded to treatment arms. |