Safety and efficacy of COVID-19 hyperimmune globulin (HIG) solution in the treatment of active COVID-19 infection- Findings from a Prospective, Randomized, Controlled, Multi-Centric Trial
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Abstract
Background
COVID-19 hyper-immune globulin (HIG) solution is a human plasma-derived, highly-purified, concentrated, virus-inactivated preparation of neutralizing antibodies (NAbs) against COVID-19.
Methods
This was a randomized, two-arm, controlled, multi-center trial to evaluate the efficacy and safety of COVID-19 HIG in patients who were hospitalized with moderate-severe COVID-19 infection.
Results
A total of 60 patients were randomized (30 in each arm). Overall, COVID-19 HIG was well-tolerated without any serious treatment-emergent adverse event or tolerability issue. The mean change in ordinal scale by day 8 was 1.7±1.61 in the test arm vs. 2.0±1.68 in the control arm (mITT; p=0.367). Early and high NAbs were observed in the test arm compared to the control arm.
More patients had negative RT-PCR by day 3 for the test arm vs. the control arm (mITT: 46.67% in test vs. 37.93% in control). The median time to be RT-PCR negative was 5.5 days for the test arm vs. 8.0 days for the control arm for PP population. Patients receiving COVID-19 HIG showed early improvement (reduction) in the biomarkers (CRP, IL-6, and D-dimer).
Conclusion
COVID-19 HIG was found to be safe and well-tolerated. Early and high NAbs were achieved in COVID-19 HIG recipients qualifying the product as a suitable treatment option, particularly in an immunocompromised state. It should be given early in infection to mitigate progression to severe disease. It should be evaluated for post-exposure prophylaxis as well as for prevention (where a vaccine is not suitable or effective). It should be evaluated in the pediatric population as well.
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SciScore for 10.1101/2021.07.26.21261119: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial was conducted in accordance with the applicable ethical standards and Good Clinical Practices guidance at seven sites after obtaining ethics committee approval and registration on the clinical trial registry of India (CTRI/2020/09/027903).
Consent: All the trial participants had signed the informed consent document.Sex as a biological variable 05), the female participant having a negative pregnancy test. Randomization This was a prospective, open-label, two-arm, randomized, controlled, multi-centric trial for evaluation of efficacy and safety of COVID-19 HIG solution manufactured by Intas Pharmaceuticals Ltd. India. Blinding not detected. Power Analysis not detected. Table 2: Resources
SciScore for 10.1101/2021.07.26.21261119: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial was conducted in accordance with the applicable ethical standards and Good Clinical Practices guidance at seven sites after obtaining ethics committee approval and registration on the clinical trial registry of India (CTRI/2020/09/027903).
Consent: All the trial participants had signed the informed consent document.Sex as a biological variable 05), the female participant having a negative pregnancy test. Randomization This was a prospective, open-label, two-arm, randomized, controlled, multi-centric trial for evaluation of efficacy and safety of COVID-19 HIG solution manufactured by Intas Pharmaceuticals Ltd. India. Blinding not detected. Power Analysis not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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