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NCT06084351
Phase 3 Open-Label Controlled Trial of Convalescent Plasma in Early COVID-19 Infection
Phase 3 trial testing Convalescent Plasma in Covid19. Withdrawn.
30 October 2020
Quick facts
| Lead sponsor | Larkin Community Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 12 May 2020 |
| Primary completion | 30 October 2020 |
| Estimated completion | 30 October 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Convalescent Plasma — full drug profile →
- Standard of Care
Conditions studied
- Covid19 — all drugs for Covid19 →
Sponsor
Larkin Community Hospital
Who can join
Adults 40 to 65, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The expanded access program for investigational convalescent plasma (CP) is being utilized nationwide despite its unproven benefit and optimal timing of transfusion. The optimal administration of CP during a viral pandemic must consider the supply of the product, ideal patient selection, and appropriate timing in order to produce maximum benefit with a scarce resource \[2\]. Currently, the FDA suggested guidelines for use include "severe", "critical" or at risk for critical disease. The optimal administration of CP with anti-SARS-CoV-2 antibodies is theoretically early in the course of the illness \[1\], before multiorgan failure or a maladaptive immune response, like seen in the cytokine release syndrome, occurs. Our open-label trial will randomize COVID-19+ patients admitted to the hospital who are at high risk for severe disease to receive 1 dose CP ordered within 48 hours of admission plus standard of care vs. standard of care. The primary clinical endpoint will be time to clinical improvement within 28 days after randomization (based on the ordinal scale as specified below). The purpose of this trial will be to obtain data which can be further utilized in future clinical trials and help clinicians understand the effectiveness of CP.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06084351
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Convalescent Plasma
Trials testing the same drug.
- NCT04884477 — COVID-19 Infection in Patients Receiving Anti-CD20 Therapy · completed
- NCT04539275 — VA CoronavirUs Research and Efficacy Studies-1 · Phase 3 · terminated
- NCT04456413 — Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection · Phase 2 · terminated
- NCT04558476 — Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation · Phase 2 · completed
- NCT04513158 — Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection · Phase 2 · terminated
Other recruiting trials for Covid19
Currently open trials in the same condition.
- NCT03305341 — Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix · EARLY_PHASE1 · active not recruiting
- NCT06482138 — Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation · NA · recruiting
- NCT04924803 — Community Developed Technology-Based Messaging to Increase COVID-19 Vaccine Uptake Among People Who Inject Drugs · NA · active not recruiting
- NCT05013632 — COVID-19 International Drug Pregnancy Registry · recruiting
- NCT04806061 — Urine Alkalinisation in COVID-19 · NA · active not recruiting
Other Larkin Community Hospital trials
Trials by the same sponsor.
- NCT04854486 — Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients · Phase 3 · withdrawn
- NCT04610801 — Evaluation of the Efficacy of Xylitol Nasal Spray Against SARS-CoV-2 · Phase 3 · withdrawn
- NCT05032079 — Subzero and Scorpion Trial · NA · withdrawn
- NCT04592705 — Measurement of IL-6 and Secondary Inflammatory Markers Before and After Therapeutic Plasma Exchange (TPE) in Hospitalize · Phase 1 · unknown
- NCT04858620 — A Study to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection · Phase 3 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06084351 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Larkin Community Hospital
- Last refreshed: 16 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06084351.
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