Trial NCT04512027; CTRI/2020/09/027833
Publication Sigamani A, J Vaccines Vaccin, 2020 (published paper)
Dates: 2020-09-15 to 2020-09-19
Funding: Private (Pharmalectin Inc contracted the trial to a Contract Research Organisation – CIMED Life Sciences)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / India Follow-up duration (days): 28 | |
| Inclusion criteria | Consenting participants between the ages of 18 and 45; All patients had to have an instrumental diagnosis for COVID-19; a positive rRT-PCR for SARS-CoV-2 obtained from an outpatient collection of nasopharyngeal swabs; presence of symptoms that were not older than 72 hours; ability to provide consent to undergo repeated collection of throat and nasal swabs over the 7-day period. |
| Exclusion criteria | Oxygen saturation at admission ≤96%, high temperature ≥1000 F(≥37.50C) not controlled on oral doses of acetaminophen; known history of diabetes on oral medications or insulin therapy or interleukin-6 levels ≥3 times of laboratory reference range and / or significantly elevated levels of CRP, serum ferritin or d-dimer or a Lymphocyte / monocyte ratio ≤3 or neutrophil / lymphocyte ratio ≥5 or platelet count ≤150,000 cells per microliter; Previously tested positive and recovered for SARS-CoV-2; Participants on any chronic medications for more than 4 weeks before randomization or active malignancy or having any co-morbidity that increases risk of rapid disease progression |
| Interventions | |
| Treatment
Prolectin-M 4 g orally once every hour, maximum 40 g a day, for 5 days |
|
| Control
Standard care Definition of Standard care: Currently approved standard of care for patients without symptoms requiring hospitalisation will be provided to all | |
| Participants | |
| Randomized 10 participants (n1=5 / n2= 5) | |
| Characteristics of participants N=10 Mean age : 28.8 2 males Severity : Mild: n=10 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register SarsCoV2 viral copy number [Time Frame: 7 days from randomisation] | |
| In the report Change in absolute count of Nucleocapsid gene and a rising Ct value, estimated from serial samples of RNA extracted from a nasopharyngeal swab | |
| Documents available |
Protocol NR 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 version of the pre-print article, the study registry was used in data extraction and risk of bias assessment. It is stated a protocol appears in supplement 1, however at the time of data extraction this was not available. There is no change from the trial registration in the intervention and control treatments. All outcome timepoints reported in the pre-print were not specified in the registry. The study's report of clinical progression and negative viral conversion used verbiage such as 'No change' in lieu of reporting absolute values. |