Trial CTRI/2020/05/025013
Publication Padmanabhan U, medRixv, 2020 (preprint)
Dates: 2020-05-06 to 2020-08-08
Funding: Mixed (Medical Education & Drugs Department (MEDD), Govt. of Maharashtra, M/S Icertis Solutions Private Ltd )
Conflict of interest: No
| Methods | |
| RCT Blinding: | |
| Location :
Single center / India Follow-up duration (days): 15 | |
| Inclusion criteria | Men and non-pregnant women (aged 18-60 years) with COVID-19 admitted to hospital with laboratory-confirmed SARS-CoV-2 infection (as pre RT- PCR), with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air and radiologically confirmed pneumonia. |
| Exclusion criteria | Negative for nCOV-19 by RT-PCR ; Any co-morbidities such as renal distress, cardiac malfunction etc. at time of admission ; Any disorder in which natural immune response is altered ; Systemic lupus ; Hypogamma-globulinemia; Congenital immunodeficiency ; Sarcoidosis ; Leukaemia ; Generalised malignancy ; HIV infections or as also those on immunosuppressive therapy, corticosteroids, radiotherapy ; Inchronic eczema or other dermatological disease ; Pregnant women, lactating (breast-feeding) women |
| Interventions | |
| Treatment
Bacille Calmette-Guérin 0.1 ml of 2.0 - 8.0 x 10^6 c.f.u. injected intradermally once off |
|
| Control
Placebo Duration : 1 day | |
| Participants | |
| Randomized 60 participants (n1=30 / n2= 30) | |
| Characteristics of participants N=60 Mean age : NR 36 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0 | |
| Primary outcome | |
| In the register Primary Outcome Measures: 1.Total duration of Hospitalization with COVID-19 symptoms such as febrile respiratory distress [Time Frame: from admission until discharge] 2.Decrease in Viral Titer [Time Frame: Measured on day of enrolment, on day 7 and 1 | |
| In the report Primary endpoints of reduction in oxygen dependency, faster resolution of COVID-19 symptoms, an evaluation of viremia and favorable outcome for COVID-19 | |
| Documents available |
Protocol Yes. In English Statistical plan NR 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, the trial registration and study protocol were used in data extraction and assessment of risk of bias. There were differences between and within the trial registry, study protocol and pre-print article in population inclusion criteria and randomization methods. There were no differences in study treatments. The study achieved its pre-stated sample size. |