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Summary of COVID-19 regdanvimab studies

Studies   Meta Analysis   Hide extended summaries

1,315 patient regdanvimab early treatment RCT: 86% lower ventilation (p=0.25), 91% lower ICU admission (p=0.06), 69% lower need for oxygen therapy (p<0.0001), and 69% lower hospitalization (p<0.0001).
RCT 1,315 outpatients in South Korea, showing lower progression and improved recovery with regdanvimab.

Aug 2022, Open Forum Infectious Diseases, https://academic.oup.com/ofid/article/doi/10.1093/ofid/ofac406/6657716, https://c19p.org/kim6

210 patient regdanvimab early treatment study: 60% lower need for oxygen therapy (p<0.0001), 44% higher hospital discharge (p=0.03), and 13% shorter hospitalization (p=0.003).
Retrospective 317 hospitalized mild-moderate COVID-19 patients in South Korea showing significantly lower rates of oxygen desaturation (SpO2 <94%) at 28 days (primary outcome) with regdanvimab monoclonal antibody treatment (13%) compared to standard of care (40%). Regdanvimab also showed benefits in time to fever recovery, discharge rates, and supplemental oxygen use.

May 2022, Current Therapeutic Research, https://www.sciencedirect.com/science/article/pii/S0011393X22000145, https://c19p.org/jang3

754 patient regdanvimab early treatment PSM study: 79% lower progression (p<0.0001) and 13% shorter hospitalization (p<0.0001).
Retrospective propensity score matched analysis of 970 high-risk mild-moderate COVID-19 patients in South Korea, showing regdanvimab significantly reduced risk of disease progression or death by 77% compared to standard care alone. No deaths occurred in either group. Regdanvimab also significantly shortened hospital stay and reduced hematological adverse events.

Mar 2022, J. Korean Medical Science, https://jkms.org/DOIx.php?id=10.3346/jkms.2022.37.e102, https://c19p.org/park5

778 patient regdanvimab early treatment study: 82% lower severe cases (p=0.002), 45% lower need for oxygen therapy (p=0.05), and 8% higher hospital discharge (p=0.001).
Retrospective 778 mild COVID-19 patients showing significantly lower progression to severe disease with regdanvimab treatment.

Nov 2021, Frontiers in Immunology, https://www.frontiersin.org/articles/10.3389/fimmu.2021.772320/full, https://c19p.org/lee12

722 patient regdanvimab early treatment study: 12% shorter hospitalization (p<0.0001), 49% lower need for oxygen therapy (p<0.0001), and 68% higher hospital discharge (p<0.0001).
Retrospective 722 hospitalized mild-to-moderate COVID-19 patients in Korea showing lower risk of disease progression with regdanvimab treatment.

Jan 2023, Int. J. Infectious Diseases, https://www.sciencedirect.com/science/article/pii/S1201971222006749, https://c19p.org/jang4

2,214 patient regdanvimab early treatment study: 51% lower progression (p=0.0002) and 32% lower need for oxygen therapy (p<0.0001).
Retrospective 2,214 mild/moderate COVID-19 patients in South Korea, 1,095 treated with regdanivimab, showing lower oxygen requirements and lower progression to severe disease with treatment in the overall cohort, but not within the delta subset.

May 2023, Frontiers in Cellular and Infection Microbiology, https://www.frontiersin.org/articles/10.3389/fcimb.2023.1192512/full, https://c19p.org/kim12

398 patient regdanvimab late treatment study: 76% lower need for oxygen therapy (p=0.004).
Retrospective 398 hospitalized mild-to-moderate COVID-19 patients in South Korea eligible for regdanvimab treatment. 65 patients received regdanvimab, with significantly lower supplemental oxygen requirements (6.2% vs 20.1% in controls). After adjusting for potential confounders, regdanvimab remained associated with lower risk of requiring supplemental oxygen (OR 0.20). There was no significant difference in mortality or hospitalization time in unadjusted results.

Mar 2022, Infection & Chemotherapy, https://icjournal.org/DOIx.php?id=10.3947/ic.2021.0140, https://c19p.org/choi4

378 patient regdanvimab early treatment study: 83% lower mortality (p=0.12), 33% lower ICU admission (p=0.49), and 55% lower need for oxygen therapy (p=0.01).
PSM retrospective 378 hospitalized COVID-19 patients in Korea showing lower progression with regdanvimab treatment.

Apr 2024, Infectious Diseases and Therapy, https://link.springer.com/10.1007/s40121-024-00971-w, https://c19p.org/hwang

124 patient regdanvimab early treatment study: 71% lower mortality (p=1), 64% lower ventilation (p=0.46), and 9% shorter hospitalization (p=0.56).
Retrospective 124 hospitalized severe COVID-19 patients receiving oxygen and remdesivir treatment in South Korea. A subgroup of 25 patients also received the monoclonal antibody regdanvimab prior to remdesivir. The regdanvimab subgroup had significantly more oxygen-free days (primary outcome), higher oxygen saturation, less advanced respiratory support, and shorter oxygen supplementation duration compared to the remdesivir alone group.

Mar 2022, Tropical Medicine and Infectious Disease, https://www.mdpi.com/2414-6366/7/3/51, https://c19p.org/chae

230 patient regdanvimab early treatment study: 59% lower mortality (p=0.002).
Retrospective 230 hemodialysis patients with COVID-19, showing lower mortality with regdanvimab. Details of the adjusted results are not provided.

May 2024, Nephrology Dialysis Transplantation, https://academic.oup.com/ndt/article/39/Supplement_1/gfae069-1573-616/7677633, https://c19p.org/lee13

307 patient regdanvimab early treatment RCT: 54% lower need for oxygen therapy (p=0.11), 49% lower hospitalization (p=0.2), 49% lower progression (p=0.2), and 35% faster recovery (p=0.003).
Phase 2 RCT with 307 outpatients with mild-moderate COVID-19, showing regdanvimab (monoclonal antibody) resulted in a minor decrease in time to negative PCR test (primary endpoint) compared to placebo, which was not statistically significant. Regdanvimab did significantly reduce time to clinical recovery by 3 days compared to placebo. A composite outcome of requiring hospitalization or oxygen therapy occurred in 4.4% of regdanvimab patients versus 8.7% placebo, with greater differences in moderate disease patients (7.2% vs 15.8% placebo). No safety issues were identified.

Feb 2022, Open Forum Infectious Diseases, http://dx.doi.org/10.1093/ofid/ofac053, https://c19p.org/streinucercel
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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