Clinical Trials Logo

Clinical Trial Summary

The study RECOVER is a randomized, open-label, multicenter phase II trial, designed to assess the clinical outcome of SARS-CoV-2 disease in high-risk patients (group 1 to group 4) following treatment with anti-SARS-CoV-2 convalescent/vaccine-boosted plasma or standard of care.

Clinical Trial Description

The aim of this randomized phase-II study is to gain evidence on the effect of convalescent plasma/vaccine-boosted plasma in the treatment of SARS-CoV-2 infection in high-risk patients. High-risk is defined as SARS-CoV-2 positive infection with Oxygen saturation at ≤ 94% at ambient air with additional risk features as categorized in 4 groups: - group 1, pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less. - group 2, chronic immunosuppression not meeting the criteria of group 1 - group 3, age ≥ 50 - 75 years meeting neither the criteria of group 1 nor group 2 and at least one of these criteria: Lymphopenia < 0.8 x G/l and/or D-dimer > 1μg/mL - group 4, age ≥ 75 years meeting neither the criteria of group 1 nor group 2 The duration of the trial for each patient is expected to be about 3 months, including two days of intervention (infusion of CP/PVP), followed by a follow-up of 3 months. Furthermore viral load is measured in nasopharagyngeal swabs at day 1, 3, 5, 10, 14, 28 or until hospital discharge within 84 days after randomization. Treatment response is assessed daily until day 28, thereafter weekly until day 56, and finally at day 84. Patients randomized into the standard arm of the study have the possibility to cross over into the experimental arm of the study starting at day 10 (+ 2 days) in case of not improving or worsening clinical condition. In total 174 patients are planned to be enrolled in the study. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05200754
Study type Interventional
Source University Hospital Heidelberg
Contact Carsten Mueller-Tidow, Prof. Dr.
Phone +49 6221-56 8001
Status Recruiting
Phase Phase 2
Start date September 3, 2020
Completion date June 2022

See also
  Status Clinical Trial Phase
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04593641 - This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19) Phase 1
Completed NCT04583995 - A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom Phase 3
Recruiting NCT06255860 - SARS-COV-2 Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study
Recruiting NCT04516811 - Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19 Phase 3
Recruiting NCT05012826 - Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID N/A
Completed NCT05007236 - Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection. Phase 2
Recruiting NCT06026514 - Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults Phase 1
Completed NCT05523739 - Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients Phase 1
Suspended NCT04738136 - Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia Phase 2
Recruiting NCT04584658 - Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)
Recruiting NCT04547114 - Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
Completed NCT05119348 - Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments N/A
Completed NCT05096962 - COVID-19: SARS-CoV-2-CZ-PREVAL-II Study
Recruiting NCT04534400 - Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure
Completed NCT04527354 - Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia Phase 2
Completed NCT04583982 - ImmuneSense™ COVID-19 Study
Completed NCT05077176 - Phase 3 Booster Vaccination Against COVID-19 Phase 3
Completed NCT05584189 - COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability N/A
Completed NCT04600999 - Clinical Trial of Favipiravir Treatment of Patients With COVID-19 Phase 3