Convalescent Plasma for Treatment of COVID-19

Joakim Dillner

Status and phase: Completed; Phase 3; Phase 2

Conditions: Covid19

Treatments: Biological: SARS-CoV-2 convalescent plasma; Other: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT04649879

CP3

Details and patient eligibility

About

Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicate that it is safe for treatment of COVID-19. We found that viremia upon admission identifies patients at 7 fold increased risk of admission to intensive care and 8 fold increased risk of death. CP treatment appeared to result in rapid viral clearance in a small case series. CP appeared to be well tolerated in a phase I study in which patients only received one dose of CP and a phase II study in which CP was given until viremia disappeared (unpublished data).

Randomised controlled studies assessing the efficacy of CP are lacking and thus the efficacy of CP is unknown. Preliminary data indicate that treatment should be given early, prior to development of severe illness. Detection of viremia upon admission identifies a group at high risk of severe disease and death that has the most to benefit from CP. Phase II study data indicates that treatment should be given until SARS-CoV-2 is no longer detected in serum and the donor antibody neutralization titres should be ≥1/640. A randomised controlled trial in which viremic patients are treated with CP with the equivalent of an antibody titre ≥1/640 is thus required to determine if CP can be an effective COVID-19 treatment.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than or equal to 18
• Admitted to a study hospital
• Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples and blood
• Negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential
• Written informed consent after meeting with a study physician and ability and willingness to complete follow up

Exclusion criteria

• No matching plasma donor (Exact matching in the ABO system is required)
• Unavailability of plasma
• Estimated glomerular filtration rate <30 (kidney failure stage III or more)
• Pregnancy (urinary-hcg)
• Breast feeding
• Inability to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

59 participants in 2 patient groups

Convalescent plasma treatment

Experimental group

Description:

* Participants will receive 200 ml convalescent plasma daily until SARS-CoV-2 is no longer detectable in the blood up to a maximum of 10 CP infusions. * If steroid therapy has not already been initiated, betamethasone 3 mg daily will be given concomitantly with steroid therapy or longer if clinically indicated but for a maximum of 10 days.

Treatment:

Biological: SARS-CoV-2 convalescent plasma

Control

Active Comparator group

Description:

Standard of care for COVID-19 patients.

Treatment:

Other: Standard of care