COVID-19 Clinical Trial
Official title:
Low Dose Radiation Therapy for Covid-19 Pneumonia: A Pilot Study
Verified date | August 2020 |
Source | All India Institute of Medical Sciences, New Delhi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Radiotherapy in low doses (30 to 100 cGy) was a popular treatment of viral pneumonias until 1940s. Low dose radiation therapy (LDRT) could possibly reduce the inflammation and prevent the cytokine storm thus mitigating the severity of pneumonitis. This is a single arm study designed to assess the feasibility and clinical efficacy of low dose radiation therapy (70 cGy in single fraction) in the patients with COVID-19 pneumonia. A total of 10 eligible patients (as per inclusion criteria) will be recruited and response will be assessed based on the symptomatic improvement or deterioration by using the National Early Warning Score (NEWS). The NEWS score will be recorded on baseline and then on Day 3, Day 7 and Day 14.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | September 2020 |
Est. primary completion date | August 27, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Confirmed cases of Covid-19 (by RT-PCR). 2. Age >18 years. 3. Patients with National Early Warning Score (NEWS) score = 5. 4. Consent Exclusion Criteria: 1. Patients on mechanical ventilatory support. 2. Hemodynamically unstable patients |
Country | Name | City | State |
---|---|---|---|
India | All India Institute of Medical Sciences, New Delhi | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi |
India,
Calabrese EJ, Dhawan G. How radiotherapy was historically used to treat pneumonia: could it be useful today? Yale J Biol Med. 2013 Dec 13;86(4):555-70. — View Citation
Kirkby C, Mackenzie M. Is low dose radiation therapy a potential treatment for COVID-19 pneumonia? Radiother Oncol. 2020 Jun;147:221. doi: 10.1016/j.radonc.2020.04.004. Epub 2020 Apr 6. — View Citation
Sbiti-Rohr D, Kutz A, Christ-Crain M, Thomann R, Zimmerli W, Hoess C, Henzen C, Mueller B, Schuetz P; ProHOSP Study Group. The National Early Warning Score (NEWS) for outcome prediction in emergency department patients with community-acquired pneumonia: results from a 6-year prospective cohort study. BMJ Open. 2016 Sep 28;6(9):e011021. doi: 10.1136/bmjopen-2015-011021. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptomatic improvement by National Early warning score (NEWS) | NEWS score | Day 3 | |
Primary | Symptomatic improvement by National Early warning score (NEWS) | NEWS score | Day 7 | |
Primary | Symptomatic improvement by National Early warning score (NEWS) | NEWS score | Day 14 | |
Primary | Length of hospital stay | Days | 30 days or date of death whichever is earlier | |
Primary | Number of ICU admissions or deaths | Number of patients | 30 days |
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