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C3PO


Title Clinical Trial of COVID-19 Convalescent Plasma in Outpatients (C3PO)
Therapeutic Area Covid-19
Principal Investigator Sunil Shroff, MD
Min Age 18 Years
Gender Any
Contact Sunil Shroff, MD
(617) 636-9631
sshroff@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04355767

Overview

A multicenter, two arm, randomized, single-blind clinical trial to determine if receiving one dose of convalescent plasma (CP) for mild COVID-19 illness prevents illness progression.

Study Details

Inclusion Criteria

  • Symptoms of COVID0-19 illness
  • Laboratory confirmed COVID-19 infection
  • Duration of symptoms less than 7 days

Exclusion Criteria

  • Age less than 18
  • prisoner or ward of state
  • unable to complete follow up assessments

Study Requirements

  • You will receive usual treatment for COVID-19 illness, no matter to which study group you are assigned.
  • We will draw up to a teaspoon of blood (5 ml) to check your blood type to make sure that any CP we give you is compatible with your blood type according to the usual practice at your hospital and local blood bank. We may draw two separate samples of blood (two needlesticks, and two teaspoons, 10 ml, total) in order to confirm your blood type
  • In the unusual case that no CP is available that is compatible with your blood type, you will not be able to participate in this research. In that case, we will not perform any further research activities. You will continue to receive usual treatment.
  • You will be randomly, that is by chance, (like the flipping of a coin), assigned to receive either CP or placebo. The placebo is water mixed with minerals and vitamins that is not known to help fight COVID infection, and has no pharmaceutical ingredient for this condition. The CP or placebo infusion will be given only once. This single dose is given only on the day of enrollment. The total volume of the infusion you will receive is about 250 ml or less (about the size of a can of soft-drink).
  • On the day of enrollment, we will also collect a tablespoon (15 ml) of blood prior to the study infusion and one hour after the infusion.
  • Information from your medical records will also be collected.
  • Your contact information and the contact information for one or more family members, close friends, or caregivers will be collected so we can perform telephone interviews and send you emails during the study.
  • We will contact you by telephone, text, or email six times to see how you are doing. This will happen every other day after the infusion for two weeks. We will ask about your symptoms, if you have had any additional medical problems, and if any contact information has changed. These phone calls or email responses will take about 10 minutes each. If you are unable to answer because of your medical condition, we will ask a family member or close friend or caregivers that you designate to report how you are doing.
  • We will also call to arrange follow up visits at 15 and 30 days after the infusion of CP or placebo. At these follow up visits we will draw one tablespoon (15 ml) of blood and ask you questions about how you are doing.