COVID-RT-01: Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2), COVID-19

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT04598581
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.2
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).

Condition or Disease	Intervention/Treatment	Phase
Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)	Radiation: Low Dose Radiation Therapy (LD-RT); Other: Sham irradiation	N/A

Detailed Description

Management of patients with SARS-CoV-2 presents a great challenge in the ongoing pandemic. The inflammatory reaction, evident in the later stages of the disease, is linked with high mortality rates. Pharmaceutical interventions at this stage often do not achieve the desired effects. Low Dose Radiation Therapy (LD-RT) has been utilized for treatment of inflammatory conditions because of its immunomodulatory effects. Thus, LD-RT may be an option in SARS-CoV-2 based on pre-clinical models and early clinical data. This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: Information on group allocation will not be disclosed to either the patient or the ICU-staff.
• Primary Purpose: Treatment
• Official Title: Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)
• Actual Study Start Date: Nov 2, 2020
• Actual Primary Completion Date: Apr 9, 2021
• Actual Study Completion Date: Apr 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low Dose Radiation Therapy (LD-RT)	Radiation: Low Dose Radiation Therapy (LD-RT); Low Dose Radiation Therapy (LD-RT) of both lungs with 1 Gray
Sham Comparator: Sham irradiation	Other: Sham irradiation; Sham irradiation

Outcome Measures

Primary Outcome Measures

1. Ventilator free days (VFD) [at day 15 after LD-RT]

   Ventilator free days (VFD)

Secondary Outcome Measures

1. Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2) [at day 5, 10, 15, 28 after LD-RT]

   Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2)

2. Overall mortality [at day 15 and 28 after LD-RT]

   Overall mortality

3. Change in levels of ferritin (ng/ml) [up to day 15 after LD-RT]

   Change in levels of ferritin (ng/ml)

4. Change in levels of c-reactive protein (mg/l) [up to day 15 after LD-RT]

   Change in levels of c-reactive protein (mg/l)

5. Change in levels of white blood cell counts (number of white blood cells per volume of blood) [up to day 15 after LD-RT]

   Change in levels of white blood cell counts (number of white blood cells per volume of blood)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age of male patients >40 years

• Age of female patients >50 years

• Patients with SARS-CoV-2 requiring mechanical ventilation

• Informed consent obtained by the legal representative of the patient

Exclusion Criteria:

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiooncology, University Hospital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

• Principal Investigator: Alexandros Papachristofilou, Dr. med., Department of Radiooncology, University Hospital Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT04598581
• Other Study ID Numbers: 2020-02047qu20Papachristofilou
• First Posted: Oct 22, 2020
• Last Update Posted: Apr 19, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: Low dose radiation therapy (LD-RT)
• Additional relevant MeSH terms: Coronavirus Infections; Severe Acute Respiratory Syndrome; Syndrome

Study Results

No Results Posted as of Apr 19, 2021