COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04393948

David Kozono

Thomas Johnson, tjohnson45@bwh.harvard.edu (PI email not reported)

2020-05-19

Withdrawn

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria - diagnosis of sars-cov-2 infection by rt-pcr or another approved laboratory test ≤ 3 days before enrollment or ≤ 14 days before enrollment with progressive disease suggestive of ongoing sars-cov-2 infection; retesting allowed - current hospitalization for ≤ 14 days with sars-cov-2 infection at the time of enrollment - use of supplemental oxygen or oxygen saturation ≤ 94% on room air - age ≥ 40 - may receive antiviral medication (e.g., remdesivir, lopinavir/ritonavir, oseltamivir, favipiravir), antibiotics (e.g., azithromycin), chloroquine, hydroxychloroquine, corticosteroids, statins, anticoagulation, antiplatelet agents (e.g., aspirin) and/or convalescent plasma from recovered individuals off study and/or on study if permitted by the other protocol exclusion criteria - prior or planned treatment with interleukin inhibitors (e.g., tocilizumab, canakinumab, sarilumab) or tnf-α inhibitors within 14 days of enrollment - prior lobectomy or pneumonectomy - prior thoracic radiotherapy with cumulative lung v20 > 15% to either lung within 1 year of enrollment, or any radiotherapy resulting in a maximum lung dose of 100 cgy or higher within 14 days of enrollment - prior chemotherapy or other systemic therapy with potential for pulmonary toxicity or radiosensitization within 14 days or 5 half-lives, whichever is greater, of enrollment, e.g., bleomycin or gemcitabine - prior cancer immunotherapy with an immune checkpoint inhibitor within 60 days of enrollment - severe pre-existing heart disease, e.g., new york heart association (nyha) functional class ≥ 3 congestive heart failure - history of bone marrow or solid organ transplantation - known history of autoimmune collagen vascular disease, e.g., scleroderma - known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or fanconi anemia - pregnancy - inability to be positioned supine and flat for radiation planning and delivery - inability to provide informed consent or lack of an authorized representative who can provide informed consent

None

3

Brigham and Women's Hospital

40

None

United States

Severe disease at enrollment

6: Severe disease at enrollment

0

Phase 1: Feasibility and safety of treating hospitalized patients with SARS-CoV-2 pneumonia with single or bilateral whole lung irradiation;Phase 2: Proportion with clinical improvement on a 7-point ordinal scale on day 4 after randomization

None

Phase 1/Phase 2

[{"arm_notes": "100 cGy single", "treatment_id": 755, "treatment_name": "Lung irradiation", "treatment_type": "Radiation therapy", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "100 cGy bilateral", "treatment_id": 755, "treatment_name": "Lung irradiation", "treatment_type": "Radiation therapy", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]