COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04482712

Dean L Kellogg, MD, PhD

kelloggd@uthscsa.edu

2020-07-22

Withdrawn

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: over 60 years of age clinically judged to require hospitalization sars-cov2 infection documented by positive rt-pcr nasopharyngeal swab mild to moderate clinical status defined as clinical symptoms with or without pneumonia on imaging, with or without fever who are judged to require hospital admission elevated ferritin lymphopenia bilateral opacities on chest x-ray low pro-calcitonin clinical signs suggestive of symptoms of mild illness with covid-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea or moderate illness with covid-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (spo2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute.

known or suspected allergy to rapa high pro-calcitonin sars-cov2 documented by negative rt-pcr nasopharyngeal swab treatment with contraindicated concomitant medications: currently receiving immunosuppressants, including steroids, prior to enrollment, or with immunomodulators or immunosuppressant drugs, including but not limited to inter leukin (il)-6 inhibitors, tumor necrosis factor (tnf) inhibitors, anti-il-1 agents and janus kinase (jak) inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization. currently receiving immunosuppressants, including steroids, prior to enrollment serious underlying disease including but not limited to cardiac, pulmonary, renal, hepatic (bilirubin >1.5x upper normal limit (uln) or aspartate aminotransferase (ast)>uln but bilirubin ≤ uln), endocrine (diabetes) or psychiatric disorders judged to be at risk in participating by the inpatient attending physician or team suspected or confirmed history of alcohol or substance abuse disorder having participated in other drug trials in the past month deemed otherwise unsuitable for the study by researchers clinically judged to not require hospital admission

2

The University of Texas Health Science Center at San Antonio

60

100

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

0

Survival rate

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 1063, "treatment_name": "Rapamycin", "treatment_type": "Other anti-infectives", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]