NCT04380818

Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19

Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Grupo de Investigación Clínica en Oncología Radioterapia · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Low radiation doses produce anti-inflammatory effects, which may be useful in the treatment of respiratory complications of COVID-19. This type of treatment is non-invasive and therefore, a priori, it can be used in all types of patients. Main objective: To evaluate the efficacy of low-dose lung irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to the pre baseline measurement. -irradiation.

Detailed description

Study design: This is a prospective multicenter study in 2 phases: 1. Exploratory phase. It will include 10 patients, to assess the feasibility and efficacy of low-dose lung irradiation. If a minimum efficiency of 30% is not achieved, the study will not be continued. 2. Comparative phase in two groups, a control group, which will only receive pharmacological treatment, and an experimental one. It will include 96 patients, the allocation will be 1: 2, that is, 32 in the control arm and 64 in the experimental arm, which will receive low-dose lung irradiation.

Conditions

• Pneumonia, Viral

Interventions

Type	Name	Description
RADIATION	Low-dose radiotherapy	Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later
DRUG	Hydroxychloroquine Sulfate	200 mg/12h for 5 days
DRUG	Ritonavir/lopinavir	400/100 mg/12h for 7-10 days
DRUG	Tocilizumab Injection [Actemra]	600 mg/day for 1-2 doses
DRUG	Azithromycin	500 mg/24h for 3 days
DRUG	Corticosteroid	Corticosteroids (methylprednisolone/dexamethasone/prednisone)
DRUG	Low molecular weight heparin	low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism
DEVICE	Oxygen supply	Oxygen

Timeline

• Start date: 2020-06-05
• Primary completion: 2021-09-04
• Completion: 2021-11-01
• First posted: 2020-05-08
• Last updated: 2021-07-30

Locations

3 sites across 1 country: Spain