Publication Esquivel-Moynelo I, medRxiv, 2020
Funding: Public/non profit (Center for Genetic Engineering and Biotechnology and Ministry of Health of Cuba)
Single center / Cuba |
Follow-up duration (days): 14
|Inclusion criteria||Adult (≥19 years-old) patients with RT-PCR confirmed SARS-CoV-2, ECOG functional status ≥ 2 (Karnofsky ≥ 70%), and voluntariness by signing the informed consent were included.|
|Exclusion criteria||Patients with each of the following characteristics were excluded: decompensated chronic diseases at the time of inclusion (severe arterial hypertension, ischemic heart disease, diabetes mellitus, etc.), with a history of autoimmune diseases, presence of hyper inflammation syndrome, serious coagulation disorders, known hypersensitivity to any of the components of the formulation under evaluation, pregnancy or lactation, and obvious mental incapacity to issue consent and act accordingly with the study.|
IFN alpha2b+IFN gamma (3.0 MIU/0.5 MIU)
Co-Intervention: Standard care
Duration : 2 weeks
Interferon alpha2b (3.0 MIU)
79 participants (n1=41 / n2= 38)
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=63 / Moderate: n=*/ Severe: n=* Critical: n=*
|In the register|
Registro Publico Cubano de Ensayos Clinicos: In Spanish
Quote from International Clinical Trials Registry Platform: "1.Time until the negativity of the SARS-Cov-2 RNA (absence of the virus according to the qPCR technique in real time) in positive patients after starting antiviral therapy 2.Time to progression to severe COVID-19."
|In the report|
Time to SARS-CoV-2 RNA negativization (absence of the virus according to the RT-PCR) in positive patients after starting antiviral therapy was the virological endpoint.
The clinical evaluation considered the time to progression to severe COVID-19.
Yes. In English
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
In addition to all available versions of the published article, the study registry, protocol, and statistical analysis plan were used in data extraction and risk of bias assessment. The study didn't achieve the target sample size specified in the trial registry (120). The trial registry was in Spanish but there were some discrepancies in study arm descriptions (duration, standard care definition) between the trial protocol and preprint. |
Quote from protocol: "The intervention group will receive the standard of care as well as, Kaletra and chloroquine as described, and HeberFERON. HeberFERON will be administered two times per week at 3.5 MIU for 3 weeks. The control group will receive standard of care as well as Heberon Alpha R, Kaletra, and chloroquine. Heberon Alpha R will be administered three times per week at 3.0 MIU for 3 weeks, with Kaletra and chloroquine".
Quote from preprint: "Patients received 3.0 million international units (MIU) IFN-α2b and 0.5 MIU IFN-γ (HeberFERON), twice a week for two weeks, subcutaneously and lopinavir-ritonavir 200/50 mg every 12 h and CQ 250 mg every 12 h (treatment group); or standard of care (3.0 MIU IFN-α2b (Heberon Alpha R), thrice a week, intramuscularly and lopinavir-ritonavir 200/50 mg every 12 h and CQ 250 mg every 12 h (control group)."
Primary outcomes from the registry are reported in the paper, but not secondary outcomes.