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

  • Clinicaltrials.gov identifier

    NCT04390178

  • Recruitment Status

    Active, not recruiting

  • First Posted

    May 15, 2020

  • Last update posted

    May 15, 2020

Study Description

Brief summary:

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. 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.

  • Condition or Disease:COVID-19
  • Intervention/Treatment: Biological: SARS-CoV-2 convalescent plasma
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 10 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: An open, non-randomised controlled, clinical trial
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Plasma From Individuals Who Have Recovered From Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection as Treatment for Acute COVID-19 Disease
  • Actual Study Start Date: April 2020
  • Estimated Primary Completion Date: June 2020
  • Estimated Study Completion Date: December 2020

Arms and interventions

Arm Intervention/treatment
Experimental: Convalescent plasma treatment
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.
Biological: SARS-CoV-2 convalescent plasma
Treatment with convalescent plasma (180-200ml) from individuals who have recovered from SARS-CoV-2 infection

Outcome Measures

  • Primary Outcome Measures: 1. Disease progression [ Time Frame: 28 days ]
    Decrease in progression to requiring non-invasive or invasive ventilation
  • Secondary Outcome Measures: 1. Adverse events (AE) [ Time Frame: The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion. ]
    Adverse reactions and serious adverse reactions. The safety of the intervention will be assessed with regard to AEs, baseline medical conditions, and findings from the physical examination and laboratory tests. Possible adverse events will be elicited using a modification and Swedish translation (appendix 6) of Common Terminology Criteria for Adverse Events v5.0 and they will be continuously reported to the sponsor. Adverse events related to convalescent plasma therapy shall be followed to assess reversibility.
  • 2. Time ro resolution of fever and symptoms [ Time Frame: Until discharged from the hospital, up to 2 months ]
    Measured daily until discharged from the hospital.
  • 3. Clearance of viraemia [ Time Frame: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion. ]
    SARS-CoV-2 RNA detection by polymerase chain reaction (PCR) in blood or serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
  • 4. Inflammatory parameters [ Time Frame: Until discharged from the hospital, up to 2 months ]
    Time to normalization of inflammatory parameters. The markers that will be monitored are the following: C-reactive protein (CRP), white blood cell count (WBC), haemoglobin (Hb), Pro-calcitonin, and Creatine Kinase. Blood samples for these markers will be taken daily until normalized or discharged from hospital.
  • 5. Antibody response to SARS-CoV-2 [ Time Frame: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion. ]
    Change in the antibody response to SARS-CoV-2 as measured in serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.

Eligibility Criteria

  • Ages Eligible for Study: 18 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Locations

Sweden
Danderyd Hospital
Danderyd

Sponsors and Collaborators

Joakim Dillner

Danderyd Hospital

Karolinska Institutet

Karolinska University Hospital

Investigators

Principal Investigator: Johan Ursing, MD, PhD Danderyd Hospital

More Information

  • Responsible Party: Joakim Dillner
  • ClinicalTrials.gov Identifier: NCT04390178 History of Changes
  • Other Study ID Numbers: CP1
  • First Posted: May 15, 2020 Key Record Dates
  • Last Update Posted: May 15, 2020
  • Last Verified: May 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: We will be sharing data but data the management plan is being designed.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Joakim Dillner: Effectiveness
    Safety
    SARS-CoV-2 infection
    COVID-19 convalescent plasma treatment
  • Additional relevant MeSH terms: COVID-19