Pharmacy and Poisons Board
Protocol No: ECCT/20/08/04 Date of Protocol: 24-08-2020
Study Title:

A pilot phase Ib/II study of whole-lung low dose radiation therapy (LDRT) in the treatment of severe Covid 19 pneumonia patients on (or requiring) mechanical ventilatory support
Study Objectives:

Primary Objective

  1. To assess the feasibility and safety of administered LDRT to patients with severe Covid 19 pneumonia
  2. To assess the toxicity of a single dose of LDRT administered to patients with severe Covid 19 pneumonia

Secondary Objectives

  1. Improvement in Oxygen requirement at 3 days following LDRT
  2. Ability to come off mechanical ventilation within 7 days following LDRT
  3. Discharge by 14d and 28d following LDRT
  4. Death by 14d and 28d following LDRT
Laymans Summary:

This research study is designed to find out if low dose radiation therapy can be safely be administered to patient with severe Covid 19 pneumonia and if this can help improve outcomes in critically ill patients with COVID-19. It is believed radiation will help improve the excess inflammation in the lungs that occurs as a complication of COVID-19. The low dose radiation is much lower than is used in the treatment of other conditions and it is believed that it will  not have significant side effects, and the risk  will be much less than that of worsening Covid 19 pneumonia which can be life threatening. 20 subjects will participate in this study. Study site will be at Aga Khan University, Nairobi
Abstract of Study:

Study description:

Hypothesis: Low-dose radiation therapy (LDRT) improves clinical, radiographic, and immune outcomes in hospitalized patients with covid-19 pneumonia and severe acute respiratory syndrome.

This study investigates LDRT as a selectively localized anti-inflammatory treatment to induce focal suppression of pulmonary immuno-toxicity within viral pneumonia infiltrates in hospitalized patients with COVID19.

 

Study: Administration of low dose whole lung radiotherapy (LDRT) for the treatment of severe COVID 19 pneumonia in patients on or requiring mechanical ventilation

Objectives:

To investigate safety and feasibility (primary endpoint) of low dose whole-lung radiation therapy (LDRT) in critically-ill patients with COVID-19 pneumonia, and to explore secondary efficacy endpoints: (1) clinical, (2) respiratory, and (3) outcome

Primary Objective:

  1. To assess the feasibility and safety of administering LDRT to patients with severe Covid 19 pneumonia
  2. To assess the toxicity of a single dose of LDRT administered to patients with severe Covid 19 pneumonia

Secondary Objective:

  1. Improvement in oxygen requirement at 3 days following LDRT
  2. Ability to come off mechanical (or avoid mechanical) ventilation within 7 days following LDRT
  3. Discharge by 14d and 28d following LDRT
  4. Death by 14d and 28d following LDRT

Endpoints

Primary

  1. Safety/Feasibility – ability to complete LDRT without treatment related SAE
  2. Toxicity – vital signs to assess clinical and respiratory status at 24h following LDRT

Secondary

  1. Efficacy - ability to be weaned off pre-LDRT ventilatory or oxygen support at 3d post LDRT
  2. Efficacy – ability to come off (or avoid) ventilatory support at 7d post LDRT
  1. Efficacy - discharge or death by 14d / 28d post LDRT

SAMPLE SIZE

Up to 20 participants will be enrolled on this study.

  • Cohort 1 (pre-Vent): Up to 10 participants
  • Cohort 2 (on-Vent): Up to 10 participants

Study population
  1. Patient with rtRTPC and Xray/CT proven Covid 19 pneumonia who have not responded to conventional therapy and:

Cohort 1: would need mechanical ventilation if condition worsens (pre-Vent)

Cohort 2: has been on mechanical ventilation, but for not more than 5 days (on-Vent)

Phase:

Pilot Phase 1b/2 study

Description of sites/facilities enrolling patients:
  1. AKUHN – a collaborative effort of the Clinical Research Unit, dept. of hematology-oncology (radiation therapy section), infectious diseases, critical care

Description of study intervention:
  1. Single dose of 100 cGy LDRT administered to both lungs within 48h of determining eligibility
  2. Cohort 1 : 5 patients will be treated. If acute treatment related SAE is observed in ≤1 of 5 patients, additional 5 patients will be treated.
  3. Cohort 2 : 5 patients will be treated. If acute treatment related SAE is observed in ≤1 of 5 patients, additional 5 patients will be treated.

If  > 1 of the initial 5 patients in either cohort experiences acute treatment related SAE, enrollment to that cohort will be halted.

Study Duration:

3 months

Participant duration:

28d from enrollment