COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56424

Pritanjali singh

drpritanjalis@aiimspatna.org

2021-06-01

Not recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

1) Age â?¥ 18 years <br/ >2) Patients with confirmed diagnosis of SARS-Cov2 infection by RT-PCR on nasopharyngeal swab and / or bronchoalveolar lavage (BAL) <br/ >3) Patients having MOHFW Moderate disease with SpO2 < 94% on Room Air and Respiratory rate > 20 Breaths per minute on Room Air with fewer than 8 days of symptom onset and currently receiving standard medication for COVID-19 at appropriate doses. Covid-19 classification criteria led down by MOHFW, Govt. Of India (Appendix 1) <br/ >4) Suggestive picture finding for interstitial pneumonia on chest X-ray and / or chest CT (optional) <br/ >5) Ability to understand and sign informed consent. <br/ >6) Ability to acquire and maintain the set-up necessary for the delivery of radiotherapy treatment <br/ >

1) Patients with MOHFW defined severe disease. <br/ >2) Patients undergoing invasive mechanical ventilation. <br/ >3) Patients with active autoimmune systemic diseases. <br/ >4) Hemodynamically unstable patients. <br/ >5) Patients with a positive pregnancy test. <br/ >6) Impossibility to maintain the set-up necessary for radiotherapy treatment. <br/ > <br/ >

2

All India Institute of Medical Sciences Patna

18

70

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

22

Primary objective: To evaluate change from moderate to severe grade of disease in both the group with NEWS-2 <br/ > <br/ > <br/ > <br/ >Timepoint: Time Frame Day 1; Day 3; Day 7; Day 14 <br/ >

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 746, "treatment_name": "Low dose radiation therapy", "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"}]