Trial reportInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2022
Repeat subcutaneous administration of casirivimab and imdevimab in adults is well-tolerated and prevents the occurrence of COVID-19.
Trial report in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.
- SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19.The Cochrane database of systematic reviews · 2022Pooled it
- Human monoclonal antibody F61 nasal spray effectively protected high-risk populations from SARS-CoV-2 variants during the COVID-19 pandemic from late 2022 to early 2023 in China.Emerging microbes & infections · 2024Trial
- Effect of Early Administration of Casirivimab and Imdevimab in Hospitalized Patients with COVID-19: A Post Hoc Analysis.Infection and drug resistance · 2026Article
- The role of large immune complexes in anti-drug antibody development: a case study of anti-SARS-CoV-2 antibody therapeutics and co-administered mRNA vaccine.Frontiers in immunology · 2026Article
- Association of Immunogenicity and Drug Exposure and the Importance of Target Engagement in ADA Development: A Clinical Case Study of Anti-SARS-CoV-2 Biotherapeutics.The AAPS journal · 2025Article
- Early antiviral CD4+ and CD8+ T cells are associated with upper airway clearance of SARS-CoV-2.JCI insight · 2024Article
- Efficacy and safety of casirivimab and imdevimab for preventing and treating COVID-19: a systematic review and meta-analysis.Journal of thoracic disease · 2024Article
- COVID-19 therapeutics.Clinical microbiology reviews · 2024Review
- Pre-Exposure Prophylaxis and Treatment with Tixagevimab/Cilgavimab for COVID-19 among Immunocompromised Pediatric Patients.Journal of clinical medicine · 2024Article
- Anti-hemagglutinin monomeric nanobody provides prophylactic immunity against H1 subtype influenza A viruses.PloS one · 2024Article
- Article
- Monoclonal antibody levels and protection from COVID-19.Nature communications · 2023Article
- How Protective are Antibodies to SARS-CoV-2, the Main Weapon of the B-Cell Response?Stem cell reviews and reports · 2023Review
- A Comprehensive Review on the Efficacy of Several Pharmacologic Agents for the Treatment of COVID-19.Life (Basel, Switzerland) · 2022Review
- Monoclonal antibody therapies against SARS-CoV-2.The Lancet. Infectious diseases · 2022Review
- Breakthrough COVID-19 cases despite prophylaxis with 150 mg of tixagevimab and 150 mg of cilgavimab in kidney transplant recipients.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2022Article
- COVID-19 vaccines in patients with cancer: immunogenicity, efficacy and safety.Nature reviews. Clinical oncology · 2022Review
- Case report: Variant-specific pre-exposure prophylaxis of SARS-CoV-2 infection in multiple sclerosis patients lacking vaccination responses.Frontiers in immunology · 2022Article
- [Antiviral drugs : Potent agents, promising therapies for COVID‑19 and therapeutic limitations].Der Internist · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
31 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesA phase 1, double-blind, placebo-controlled trial was conducted to evaluate the safety, tolerability, and exploratory efficacy of repeat monthly doses of subcutaneous (SC) casirivimab and imdevimab (CAS+IMD) in uninfected adult volunteers.
methodsParticipants were randomized (3:1) to SC CAS+IMD 1200 mg or placebo every 4 weeks for up to six doses. Primary and secondary end points evaluated safety, pharmacokinetics, and immunogenicity. Exploratory efficacy was evaluated by the incidence of COVID-19 or SARS-CoV-2 seroconversion.
resultsIn total, 969 participants received CAS+IMD. Repeat monthly dosing of SC CAS+IMD led to a 92.4% relative risk reduction in clinically defined COVID-19 compared with placebo (3/729 [0.4%] vs 13/240 [5.4%]; odds ratio 0.07 [95% CI 0.01-0.27]), and a 100% reduction in laboratory-confirmed COVID-19 (0/729 vs 10/240 [4.2%]; odds ratio 0.00). Development of anti-drug antibodies occurred in a small proportion of participants (<5%). No grade ≥3 injection-site reactions (ISRs) or hypersensitivity reactions were reported. Slightly more participants reported treatment-emergent adverse events with CAS+IMD (54.9%) than with placebo (48.3%), a finding that was due to grade 1-2 ISRs. Serious adverse events were rare. No deaths were reported in the 6-month treatment period.
conclusionRepeat monthly administration of 1200 mg SC CAS+IMD was well-tolerated, demonstrated low immunogenicity, and showed a substantial risk reduction in COVID-19 occurrence.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.