Randomized Controlled Phase 2b Clinical Study in Parallel Groups for the Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma Plus Standard Treatment vs. Standard Treatment Alone of Subjects With Severe COVID-19

Schiffer et al., NCT04712344, IPCO, NCT04712344, Sep 2021

Estimated 58 patient convalescent plasma late treatment RCT with results not reported over 4 years after estimated completion.

29 convalescent plasma RCTs have results missing long after expected1-29
The trials report a total of 3,534 patients, with 15 trials having actual enrollment of 1,143, and the remainder estimated.

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1. Baylor Research Institute, Evaluating Convalescent Plasma to Decrease Coronavirus Associated Complications. A Phase I Study Comparing the Efficacy and Safety of High-titer Anti-Sars-CoV-2 Plasma vs Best Supportive Care in Hospitalized Patients With Interstitial Pneumonia Due to COVID-19, NCT04333251, clinicaltrials.gov/study/NCT04333251clinicaltrials.gov.

2. Perner et al., Plasma Exchange (PLEX) and Convalescent Plasma (CCP) in COVID-19 Patients With Multiorgan Failure - the COVID PLEX+CCP Trial, NCT04634422, clinicaltrials.gov/study/NCT04634422clinicaltrials.gov.

3. Itinose et al., Validation Protocol for The Clinical Use of Convalescent Plasma for Hospitalized Patients With COVID-19. A Prospective Study at a Hospital in Southern Brazil., NCT05077930, clinicaltrials.gov/study/NCT05077930clinicaltrials.gov.

4. Rego et al., Efficacy and Safety of Using Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support, NCT04528368, clinicaltrials.gov/study/NCT04528368clinicaltrials.gov.

5. Dillner et al., Convalescent Plasma for Treatment of COVID-19: An Open Randomised Controlled Trial, NCT04649879, clinicaltrials.gov/study/NCT04649879clinicaltrials.gov.

6. ElDesouky et al., Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection, NCT04438694, clinicaltrials.gov/study/NCT04438694clinicaltrials.gov.

7. Karyana et al., Clinical Trial of Convalescent Plasma Administration as Adjunct Therapy for COVID-19 (Uji Klinik Pemberian Plasma Konvalesen Sebagai Terapi Tambahan COVID-19), NCT04873414, clinicaltrials.gov/study/NCT04873414clinicaltrials.gov.

8. de la Puerta Rueda et al., Clinical Efficacy of the Infusion of Donor Plasma, Convalescent From SARS-CoV-2 Infection, to Patients With Recent Infection., NCT05247307, clinicaltrials.gov/study/NCT05247307clinicaltrials.gov.

9. Perilla et al., Efficacy of Convalescent Plasma for the Treatment of Severe SARS-CoV-2 Infection: A Randomized, Open Label Clinical Trial, NCT04391101, clinicaltrials.gov/study/NCT04391101clinicaltrials.gov.

10. Keitel-Anselmino et al., Reconvalescent Plasma / Camostat Mesylate Early in Sars-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals, NCT04681430, clinicaltrials.gov/study/NCT04681430clinicaltrials.gov.

11. Schiffer et al., Randomized Controlled Phase 2b Clinical Study in Parallel Groups for the Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma Plus Standard Treatment vs. Standard Treatment Alone of Subjects With Severe COVID-19, NCT04712344, clinicaltrials.gov/study/NCT04712344clinicaltrials.gov.

12. Pathak et al., A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications, NCT04374487, clinicaltrials.gov/study/NCT04374487clinicaltrials.gov.

13. Kaufman et al., A Prospective, Randomized, Double-Masked, Placebo-Controlled Trial of High-Titer COVID-19 Convalescent Plasma (HT-CCP) for the Treatment of Hospitalized Patients With COVID-19 of Moderate Severity, NCT04361253, clinicaltrials.gov/study/NCT04361253clinicaltrials.gov.

14. Gonzalez et al., Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma, NCT04468009, clinicaltrials.gov/study/NCT04468009clinicaltrials.gov.

15. Martinaud et al., Evaluation Of Efficacy Of COVID-19 Convalescent Plasma Versus Standard Plasma In The Early Care Of COVID-19 Patients Hospitalized Outside Intensive Care Units., NCT04372979, clinicaltrials.gov/study/NCT04372979clinicaltrials.gov.

16. Talarico et al., Efficacy and Safety of Hyperimmune Plasma Treatment in Patients With COVID-19 Severe Infection, NCT04385043, clinicaltrials.gov/study/NCT04385043clinicaltrials.gov.

17. Herrick et al., Infusion of Convalescent Plasma for the Treatment of Patients Infected With Severe Acute Respiratory Syndrome-Coronavirus-2 (COVID-19): A Double-blinded, Placebo-controlled, Proof-of-concept Study, NCT04442191, clinicaltrials.gov/study/NCT04442191clinicaltrials.gov.

18. Camacho-Ortiz et al., Phase II, Randomized, Double-blind, Controlled Clinical Trial Evaluating the Efficacy and Safety of Plasma From Patients Cured of COVID-19 Compared to the Best Available Therapy in Subjects With SARS-CoV-2 Pneumonia, NCT04358783, clinicaltrials.gov/study/NCT04358783clinicaltrials.gov.

19. Fundacin Biomedica Galicia Sur, PHASE II Clinical Trial Randomized And Controlled To Assess Need Of Oxygen On Day 14 After Administration Of Passive Immunotherapy In Patients Infected By SARS-CoV-2 With Risks Factors For Severe Disease, NCT05578391, clinicaltrials.gov/study/NCT05578391clinicaltrials.gov.

20. Torres et al., A Multicenter, Randomized, Open-label, Parallel Group Pilot Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19) With Standard Medical Treatment (SMT) Versus SMT Alone in Subjects With COVID-19 Requiring Admission to the Intensive Care Unit (ICU), NCT04547127, clinicaltrials.gov/study/NCT04547127clinicaltrials.gov.

21. Quintero-Vega et al., Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19: A Randomized, Controlled Study CRI-CP (Coronavirus Investigation - Convalescent Plasma), NCT04425837, clinicaltrials.gov/study/NCT04425837clinicaltrials.gov.

22. Sierra-Madero et al., Phase 2b/3 Trial to Evaluate the Safety and Efficacy of Plasma Transfusion From Convalescent Patients With SARS-CoV-2 Infection on Severity and Mortality of COVID-19 in Hospitalized Patients, NCT04388410, clinicaltrials.gov/study/NCT04388410clinicaltrials.gov.

23. Zuluaga et al., Inactivated Convalescent Plasma as a Therapeutic Alternative in Hospitalized Patients CoViD-19, NCT04385186, clinicaltrials.gov/study/NCT04385186clinicaltrials.gov.

24. Cardesa Gil et al., Phase I / II Multicentre, Randomized and Controlled Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection, NCT04366245, clinicaltrials.gov/study/NCT04366245clinicaltrials.gov.

25. Lubis et al., Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome in Referral Hospitals in Indonesia, NCT04380935, clinicaltrials.gov/study/NCT04380935clinicaltrials.gov.

26. Chowdhury et al., Convalescent Plasma Transfusion Therapy in Severe COVID-19 Patients- a Tolerability, Efficacy and Dose-response Phase II RCT, NCT04403477, clinicaltrials.gov/study/NCT04403477clinicaltrials.gov.

27. Torres (B) et al., Convalescent Plasma as a Treatment for Patients With Severe COVID-19 Disease, NCT04542967, clinicaltrials.gov/study/NCT04542967clinicaltrials.gov.

28. Averyanov et al., Randomized, Open Label, Prospective Study of the Safety and Efficacy of Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease, NCT04392414, clinicaltrials.gov/study/NCT04392414clinicaltrials.gov.

29. Sevdi et al., Effectiveness of Convalescent Immune Plasma Therapy in Severe COVID-19 Patients With Acute Respiratory Distress Syndrome, NCT04442958, clinicaltrials.gov/study/NCT04442958clinicaltrials.gov.

Schiffer et al., 1 Sep 2021, Randomized Controlled Trial, Germany, trial NCT04712344 (history) (IPCO). Contact: mario.schiffer@uk-erlangen.de, Holger.Hackstein@uk-erlangen.de.

Late treatment
is less effective