Status:
TERMINATED
Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia
Lead Sponsor:
Thomas Benfield
Conditions:
COVID
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients wit...
Detailed Description
The study is a randomized, double blinded, placebo-controlled, multicenter study with two parallel treatment arms consisting of either convalescent plasma or intravenous placebo. We plan to enroll a t...
Eligibility Criteria
Inclusion
- ≥18 years of age
- Confirmed COVID-19 infection by presence of SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR)
- Evidence of pneumonia given by at least one of the following: SpO2 ≤93% on ambient air or PaO2/FiO2 \<300 mmHg/40 kPa OR Radiographic findings compatible with COVID-19 pneumonia
- For women of childbearing potential: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period
- Signed Informed Consent Form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives
Exclusion
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
- Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by sponsor)\*
- Pregnant or breastfeeding, positive pregnancy test in a pre-dose examination
- Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2021
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT04345289
Start Date
May 1 2020
End Date
March 16 2021
Last Update
August 4 2022
Active Locations (12)
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1
Aalborg University Hospital
Aalborg, Denmark
2
Aarhus University Hospital
Aarhus, Denmark
3
Bispebjerg Hospital
Copenhagen, Denmark
4
Rigshospitalet
Copenhagen, Denmark