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NCT Number: NCT04384497

Convalescent Plasma for Treatment of COVID-19: An Exploratory Dose Identifying Study

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. However, data is limited to small studies and case series on severely ill patients.

In a preliminary safety study 10 patients with severe COVID-19, defined as requiring supplementary oxygen, having fever and a duration of illness less than 11 days were treated with 200 ml of CP. CP was given as a slow infusion without obvious adverse events. Eight patients had viremia. One patient rapidly cleared the virus and recovered following CP treatment. CP infusion did not appear to clear viremia in 7/8 patients. Five of these were eventually admitted to ICU. Thus CP did not appear to cause acute toxicity but did not seem to be effective at the dose used. Viremia seemed to be a marker of a high risk of disease progression The proposed study thus aims to treat a high risk population identified by having viremia irrespective of but hopefully before they develop pulmonary injury such that they require supplementary oxygen therapy. Moreover the dose of plasma will be increased incrementally with the aim of clearing viremia as our initial study indicates that continued viremia is driving COVID-19.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Danderyd Hospital, Danderyd, Stockholm County, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Admitted to a study hospital
  • Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
  • 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 is required)
  • Unavailability of plasma
  • Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum
  • Estimated glomerular filtration rate <60 (kidney failure stage III or more)
  • Pregnancy (urinary-hcg)
  • Breast feeding
  • History of severe allergic reactions to foods or other substances that the donor may have been exposed to (for example severe peanut allergy)
  • Inability to give informed consent

Treatment and study plan

SARS-CoV-2 convalescent plasma

Biological

Treatment with convalescent plasma (200ml, up to a maximum of 7 CP infusions). Plasma from consenting individuals who have recovered from SARS-CoV-2 infection.

Primary outcomes

  1. Number and proportion of patients with progression to ventilation or sustained requirement of supplementary oxygen therapy

    Time frame: Measured in the first 28 days after inclusion.

    Progression to non-invasive or invasive ventilation or a sustained requirement of 15L of supplementary oxygen therapy in patients that are not eligible for intensive care treatment.

Secondary outcomes

  1. Adverse events

    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. Dose of plasma needed to clear viremia

    Time frame: 28 days

    Measured as doses of convalescent plasma administered (1-7 infusions, 200ml).

  3. Clearance of viremia

    Time frame: 6 months.

    SARS-CoV-2 RNA detection by 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. Fever and symptoms

    Time frame: Until discharged from the hospital, up to 2 months

    Time to resolution of fever and symptoms. Breathing rate, peripheral oxygen saturation (measured with pulse oximetry after 20 minutes of rest), oxygen use, pulse, blood pressure, body temperature and mental state will be monitored 3 times/day while hospitalized.

  5. Inflammatory parameters

    Time frame: Until discharged from the hospital, up to 2 months

    Time to normalization of inflammatory parameters. Blood samples for inflammatory parameters will be taken daily until normalized or discharged from the hospital.

  6. Antibody response to SARS-CoV-2

    Time frame: 6 months

    Characterization of the antibody response to SARS-CoV-2. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.

Sponsors and collaborators

Lead sponsor

Joakim Dillner

Other

Collaborators

  • Danderyd Hospital
  • Karolinska Institutet
  • Karolinska University Hospital

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 12, 2020
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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