Convalescent Plasma as Treatment for Acute Coronavirus Disease (COVID-19)

Joakim Dillner

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Biological: SARS-CoV-2 convalescent plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04390178

CP1

Details and patient eligibility

About

There is currently no effective treatment for COVID-19 except best supportive care. The aim is assess the safety, tolerability and efficacy of convalescent plasma for treatment of patients with varying degrees of COVID-19 illness.

Full description

Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID-19. However, data is limited to small studies and case series on severely ill patients. The proposed study assesses the safety and efficacy earlier in the course of illness, in slightly less severe patients with the possibility of detecting less severe adverse events and the potential for early treatment to hinder the development of severe disease. Plasma is collected from consenting donors who have recovered from SARS-CoV-2.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 and <81 years
• Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
• Fever ≥38.5C, admitted to a study hospital, hypoxemia defined as having a peripheral oxygen saturation below 93% (measured by pulse oximetry) and a breathing rate of >20 breaths per minute without supplemental oxygen treatment
• A 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 both the ABO system and the Rh system is required)

• Unavailability of plasma

• Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum

• Disease duration >8 Days

• Estimated glomerular filtration rate <60 (kidney failure stage III or more)

• Pregnancy (urinary-hcg), breast feeding,

• History of severe allergic reactions

• Inability to give informed consent

• Significantly compromised immunity.*

  • Compromised immunity includes but is not limited to treatment with major immunosuppressive agents including high dose corticosteroids, anti-tumor necrosis factor (TNF) agents, calcineurin inhibitors, mTOR inhibitors, lymphocyte depleting biological agents, chemotherapeutic anti neoplastic agents. Also patients with advanced HIV/AIDS, severe immunodeficiency such as hypoglobulinemia, decompensated liver cirrhosis and bone marrow transplant the last year will be excluded.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Convalescent plasma treatment

Experimental group

Description:

All participants will receive a bag of convalescent plasma. The bag volume will be 180-200 ml. The first 10 patients will receive 1, 5, 10, 50 and 134 ml of plasma at 30 minute intervals while being closely monitored for adverse events, especially allergic reactions. The remaining twenty patients will receive the convalescent plasma as a slow infusion according to normal routines.

Treatment:

Biological: SARS-CoV-2 convalescent plasma