COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04920916

William A Petri

CLEMCOVID19@hscmail.mcc.virginia.edu

2021-06-10

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: male or female 18 years of age or older at the time of enrollment. patients hospitalized with a positive rt-pcr for sars-cov-2 within the last 14 days, with illness duration within the last 14 days, and evidence of moderate to severe covid-19 infection as defined by nih covid-19 severity categorization (8): moderate illness: individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen spo2≥ 94% on room air at sea level. severe illness: individuals who have spo2 <94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) <300 mm hg, respiratory frequency >30 breaths/min, or lung infiltrates >50%. patient and/or legally authorized representative is willing and able to provide written informed consent and comply with all protocol requirements. patients with hematologic malignancies or solid tumors are eligible. patients with autoimmune disorders are eligible. patients with immunodeficiency and organ or stem cell transplant recipients are eligible. patients with acute or chronic renal injury/failure are eligible. patients with neutropenia/lymphopenia are eligible. patients with elevated liver function tests are eligible. women who are not taking contraception are eligible. patients who are currently or have recently received steroids and/or remdesivir are eligible. patient agrees to not participate in another clinical trial for the treatment of covid-19 through end of study period.

patients who do not require inpatient admission for covid-19 infection. patients who require invasive mechanical ventilation at time of enrollment. a pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk due to study participation. pregnancy or breast feeding (lactating women who agree to discard breast milk from day 1 until two weeks after the last study product is given are not excluded). allergy to dupilumab or its excipients. received any of the following in the two weeks prior to screening as treatment of covid-19: small molecule tyrosine kinase inhibitors (e.g. imatinib, gefitinib, acalabrutinib, etc.); monoclonal antibodies targeting cytokines (e.g., tnf inhibitors, anti-interleukin-1 [il-1], anti-il-6 [or sarilumab], etc.); monoclonal antibodies targeting t-cells or b-cells as treatment for covid-19; any other immunomodulatory (other than steroids) medications within 5 half-lives or 30 days prior to randomization. current acute parasitic helminth infection or history of chronic parasitic infection. history of ocular scleritis, uveitis, keratitis or recent (<6 months) eye injury (chemical or traumatic), infection or vascular occlusion. have received any live vaccine (that is, live attenuated) within 4 weeks before screening, or intend to receive a live vaccine (or live attenuated) during the study. note: use of non-live (inactivated) vaccinations is allowed for all subjects.

2

University of Virginia

18

100

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

40

Day 28 Ventilator Free Survival;Follow up Study 1 Year Outcome: Pulmonary Function Testing- Oxygen Diffusion and 6 Minute Walk Testing

None

Phase 2

[{"arm_notes": "", "treatment_id": 424, "treatment_name": "Dupilumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]