Countering Lung Damage in COVID-19 infection: the CounterCovid Study

Phase 1

• Conditions: Covid19 is characterized by hypoxemic respiratory failure, caused by extensive vascular leak and pulmonary edema early in the course of disease.; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001236-10-NL
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-31
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 386

Inclusion Criteria

- Age >18 years
- Hospital admission with proven SARS2-Covid19 infection
- Hypoxemic respiratory failure (SaO2 <94%, PaO2 <9kPa)
- Ability to give informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 186

Exclusion Criteria

- Pre-existing chronic pulmonary disease
- Former diagnosis of Interstitial pulmonary disease
- Former diagnosis of COPD 4 or FEV1<30%pred
- Previous DLCO <45%
- Total lung capacity (TLC) < 60% of predicted
- Lung cancer with non-surgical treatment in last year
- Chronic home oxygen treatment
- Pre-existing heart failure with a known left ventricular ejection fraction <40%
- Active treatment of hematological or non-hematological cancer with targeted, immuno- or chemotherapy or targeted radiotherpay in the last year
- Inability to provide informed consent
- Any subject who had received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study
- Active liver disease, porphyria or elevations of serums transaminases >5 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN
- History or suspicion of inability to cooperate adequately.
- White blood count < 4.0^109/l
- Hemoglobin < 6.0 mmol/l
- Thrombocytes < 100^109/l
- Pregnant female subjects
- Breastfeeding female subjects
- Use of strong Cyp3A4 inductors, including the following drugs: Carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine
- Concomittant use of chloroquine or hydroxychloroquine.
- QTc >500msec at baseline.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified