Trial CTRI/2020/10/028423
Publication Lattman E, medRxiv, 2021 (preprint)
Funding: Private (PNB Vesper Life Science Pvt Ltd)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / India Follow-up duration (days): 29 | |
| Inclusion criteria | Laboratory-confirmed SARS-CoV-2 infection as determined by PCR within 2 days of randomization; patients having pneumonia with no signs of severe disease (severe disease means SpO2 ≤94%) on room air; patients with any two of the following signs or symptoms suggestive of COVID-19: fever, cough, dyspnea, or hypoxia; respiratory rate more or equal to 24 per minute; radiographic infiltrates as confirmed by imaging (chest X-ray). |
| Exclusion criteria | Required invasive mechanical ventilation; had the following clinically significant laboratory abnormalities: SGOT, SGPT, serum bilirubin > 2.5 times the Upper Limit Normal (ULN); had abnormal serum creatinine value of ≥ 2 mg/dl; had Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus with random sugar ≥ 200 mg/dL; or had uncontrolled hypertension (systolic blood pressure> 160 mm Hg, or diastolic blood pressure>100mmHg) or previous history of hypertension crisis or hypertensive encephalopathy. |
| Interventions | |
| Treatment
PNB001 100 mg orally three times a day for 14 days |
|
| Control
Standard care ( / ) Definition of Standard care: Standard of care treatment as per the revised clinical management protocol for COVID-19 as issued by Govt of India, MoHFW | |
| Participants | |
| Randomized 40 participants (n1=20 / n2= 20) | |
| Characteristics of participants N=40 Mean age : 52.5 26 males Severity : Mild: n=0 / Moderate: n=34/ Severe: n=6 Critical: n=0 | |
| Primary outcome | |
| In the register 1. Mean change in the ordinal scale from baseline. 2. Mortality Rate by Day 28 | |
| In the report Change in the 8-point WHO Ordinal Scale score for COVID-19 from baseline to Day 14 and mortality rate by Day 28. | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
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| 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 prospective trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. There were no differences between the outcomes in the registry and in the pre-print article. One outcome (improvement in oxygen saturation from baseline) was not measured because the use of other modes of oxygen administration meant that it was no longer considered a useful parameter. The study achieved its pre-specified sample size. |