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)

Torres et al., NCT04547127, NCT04547127, Feb 2021

200 patient convalescent plasma late treatment RCT with results not reported over 5 years after 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.

Important missing comments or errors? Let us know.

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.

Torres et al., 4 Feb 2021, Randomized Controlled Trial, Spain, trial NCT04547127 (history). Contact: mireia.torres@grifols.com, elsa.mondou@grifols.com.

Late treatment
is less effective