Trial RPCEC00000317
Publication Cruz LR, ACS Pharmacol. Trans, 2020 (published paper)
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
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Cuba Follow-up duration (days): 14 | |
| 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. |
| Exclusion criteria | Registry:
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. |
| Interventions | |
| Treatment
CIGB-325 2.5 mg/kg IV once a day for 5 days |
|
| Control
Standard care Definition of Standard care: Based on alpha 2b-IFN plus kaletra/hydroxyquinoline | |
| Participants | |
| Randomized 20 participants (n1=10 / n2= 10) | |
| Characteristics of participants N=20 Mean age : 45.4 14 males Severity : Mild: n=9 / Moderate: n=9/ Severe: n=2 Critical: n=0 | |
| Primary outcome | |
| In the register Reduction of the time to the negativization of the coronavirus detection test (time to the negative of the coronavirus detection test by PCR-RT in the nasopharynx). Measurement time: 48 hours and on the 7th day after starting the treatment. | |
| In the report NR | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated No |
| 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, 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. |