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 |
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Exclusion criteria |
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Interventions | |
Treatment
Prolectin-M 4 g orally once every hour, maximum 40 g a day, for 5 days |
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Control
Standard care | |
Participants | |
Randomized participants : Prolectin-M=5 Standard care=5 | |
Characteristics of participants N= 10 Mean age : NR 2 males Severity : Mild: n=10 / Moderate: n=0 / Severe: n=0 Critical: n=0 Number of vaccinated participants: NR | |
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 willing stated in the publication: Not reported |
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. |