EUCTR2020-001367-88-DK
Active, not recruiting
Phase 1
Efficacy and safety of novel treatment options for adults with COVID-19 pneumonia. A double-blinded, randomized, multi-stage, 6-armed placebo-controlled trial in the framework of an adaptive trial platform - CCAP-RCT
Department of Infectious diseases0 sites6 target enrollmentApril 1, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Department of Infectious diseases
- Enrollment
- 6
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •?\=18 years of age
- •?Confirmed COVID\-19 infection per WHO criteria / 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
- •?Radiographic findings compatible with COVID\-19 pneumonia
- •?Onset of first experienced symptom, defined as one respiratory symptom or fever, no more than 10 days before admission
- •?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 representative
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •?In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
- •?History of allergic reaction to study drug (as judged by the site investigator)
- •?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 or patients family planning within three months after receiving study agent
- •?Estimated glomerular filtration (eGFR) \<30 ml/min
- •?Severe liver dysfunction (Child Pugh score C)
- •?Known history of the following medical conditions:
- •?Active or latent tuberculosis (TB) or history of incompletely treated TB
- •?Chronic hepatitis B or C infection
- •?Retinopathy or maculopathy
Outcomes
Primary Outcomes
Not specified
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