Publication Cruz L, medRxiv, 2020 (preprint)
Dates: 2020-06-01 to 2020-06-16
Funding: Mixed (British Embassy in Cuba (FCDO); Center for Genetic Engineering and Biotechnology (CIGB); Ministry of Public Health.)
Conflict of interest: no COI
Single center / Cuba |
Follow-up duration (days): 19
|Inclusion criteria||Registry: Males and females confirmed as SARS-CoV-2 positive by RT-PCR:
1) Patients who meet the diagnostic criteria for COVID 19 in categories 1 through 4 of the NIH guidelines.
2) Age over 18 years.
3) Voluntariness of the patient by signing the informed consent.
1) Pregnancy or lactation at the time of inclusion in the study.
2) Patients included in another clinical trial.
3) Diseases that compromise the patient's state of consciousness or their possibility of giving their informed consent or collaborating in the trial.
4) Critical illness, category 5 of the NIH Guidelines.
CIGB-325 (2.5 mg/kg)
Co-Intervention: Standard care
Duration : 5 days
Definition of Standard care: Based on alpha 2b-IFN plus kaletra/hydroxyquinoline
20 participants (n1=10 / n2= 10)
|Characteristics of participants|
Mean age : 45.4
Severity : Mild: n=9 / Moderate: n=9/ Severe: n=2 Critical: n=0
|In the register|
|In the report|
|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 the pre-print, the trial registry was also used in data extraction and risk of bias assessment. Some outcomes were not reported in the paper that were pre-specified in the registry. There was a change from the trial registration in the intervention treatment.
"CIGB-300 code used for cancer treatment was substituted by CIGB-325 just after the online registration of this clinical trial; therefore, it appears labeled with the former code."
The study achieved the target sample size specified in the registry.