COVID-19LOCORADNCT04904783
Low-Dose Radiation Therapy to Lungs in Moderate COVID-19 Pneumonitis: A Case-Control Pilot Study
A study testing Low dose radiotherapy in people with COVID-19 and Pneumonia, run by Mahatma Gandhi Institute of Medical Sciences at 2 sites in India.
Trial summary
This pilot case-control study at Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sevagram, India is designed to evaluate the use of low dose radiotherapy (LDRT) in patients with moderate COVID-19 with specific objectives to abrogate the onset of cytokine storm and thus facilitate their early recovery and reduce… Read more about this study
- Who is it for?
- Ages 50 years and older
- What is being tested?
- Low dose radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Jun 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reverse transcription polymerase chain reaction (RT-PCR) / Rapid Ag test positive
- Signed informed consent
- Age ≥ 50 yrs
- Respiratory rate : 25 - 30/min, breathless AND/OR
- Oxygen saturation by pulse oximetry (SpO2) in 90 - 93% on room air (readings taken after 5 mins of stopping oxygen supplementation)
- Rising levels of quantitative-CRP and/or D-Dimer and/or Ferritin in 2 consecutive samples taken 24 hours apart
Who cannot join
- Patient who have received vaccination for COVID-19 (single / both doses of any approved vaccine)
- Hemodynamic instability in shock and/or systolic BP < 90mm Hg
- Septicemia
- Disseminated intravascular coagulation
- Requiring ventilation
- Unable to lie down supine
Show all 11Show fewer
- Severe acute respiratory distress with Fraction of inspired oxygen (FiO2) < 100mm Hg
- Cardiac defibrillator/pacemaker in situ
- Lymphocyte count < 1 x 106/ml
- Pregnancy and/or lactating mothers
- HIV and/or HbsAg positive patients
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
Mahatma Gandhi Institute of Medical Sciences,
Sevāgrām, Maharashtra, 442102
Niloy R Datta, MD, DNB, +919717388117, niloydatta@magims.ac.in
Jyoti Jain, MD, PhD, +919850517839, jyotijain@mgims.ac.in
- Recruiting
Mahatma Gandhi Institute of Medical Sciences
Sevāgrām, Maharashtra, 442102
Niloy R Datta, MD, DNB, +919717388117, niloydatta@magims.ac.in
Jyoti Jain, MD, PhD, +919850517839, jyotijain@mgims.ac.in
About this study
Official title: Low-Dose Radiation Therapy in COVID-19
This pilot case-control study at Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sevagram, India is designed to evaluate the use of low dose radiotherapy (LDRT) in patients with moderate COVID-19 with specific objectives to abrogate the onset of cytokine storm and thus facilitate their early recovery and reduce mortality.
Read the detailed description
One of the primary attributes to the mortality in coronavirus disease -19 (COVID-19) is acute respiratory distress syndrome (ARDS) induced by severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) mediated cytokine storm (CS).To mitigate the ARDS, an ideal approach would be to diminish the viral load by activating immune cells for CS prevention or to suppress the overactive cytokine-releasing immune cells. The search for ideal pharmaceutical agent/s to take care of SARS-CoV-2 mediated CS is still eluding the clinicians. The only drugs with modest clinical benefit are remdesivir and dexamethasone. The availability of the former is uncertain while an overdependence on steroids could prove counterproductive as evident from increasing incidence of fatal mucormycosis reported in post-COVID patients treated with steroids. The situation for COVID-19 patients successfully treated with steroids is akin to "from frying pan into the fire".
Thus, concerted efforts are needed to prevent the onset of CS in COVID-19. This, would directly help to lower the mortality. One of the approaches being recently investigated worldwide, is the use of single low dose radiotherapy (LDRT) of 0.5 - 1.5 Gy to the lungs before the onset of CS in moderately affected COVID-19 patients requiring oxygen supplementation. This crucial window of opportunity needs to be exploited with LDRT to mitigate the onset of the fatal CS.
LDRT could thus be a potential game changer in the management of COVID-19. LDRT with its multipronged actions may attenuate immune activation and consequently mitigate the production of pro-inflammatory cytokines. A number of centers have reported encouraging outcomes in pilot studies with LDRT. There has been a significant reduction in oxygen requirement within just 72 hours of LDRT, resulting in reduced hospital stay and deaths. This pilot case-control study at MGIMS is designed to evaluate the use of LDRT in patients with moderate COVID-19 with specific objectives to prevent the onset of CS and thus facilitate their early recovery and reduce mortality.
- Being tested
- Low dose radiotherapy
- Keywords
- COVID-19, Pneumonia, Low dose radiotherapy, Cytokine storm
- Medical subject headings
- COVID-19, Pneumonia, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose radiotherapyRadiation
Patients in study group will receive LDRT to both lungs by two parallel opposed fields, antero-posterior (AP) and postero-anterior (PA) to deliver a midplane dose of 0.5 Gy in a single fraction. As this dose is very less, doses to the critical structures including heart and lungs would be very low. All the patients will be treated on Telecobalt unit (Theratronics Phoenix, Canada) and not on the linear accelerator to avoid risks to cancer patients on treatment with linear accelerator. CT based plan will not be undertaken for logistic issues and is also not felt to be mandatory for this LDRT. Dose computation would be carried out by manual dose calculation for the Telecobalt unit.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Active comparator | 10 patients of confirmed diagnosis of moderate COVID-19 who fulfil the inclusion criteria and give written informed consent would be in study arm. All patients, belong to both study and control groups would receive the same treatment (oxygen support, steroids, anticoagulant therapy, remdesivir and other supportive therapy) as per the Institute guidelines for management of moderate COVID-19 disease. Only low dose radiotherapy would be added to patients in the study arm. Receives: Radiation: Low dose radiotherapy |
| Control Arm | No intervention | 10 patients of confirmed diagnosis of moderate COVID-19 who fulfil the inclusion criteria and have not given written informed consent would be in study arm. These patients would receive the same treatment (oxygen support, steroids, anticoagulant therapy, remdesivir and other supportive therapy) as per the Institute guidelines for management of moderate COVID-19 disease except low dose radiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients dying due to COVID-19
Compare the number of patients whose death could be ascribed to COVID-19 in the two groups
Measured: 28 days from the date of diagnosis
Mean duration of hospital stay for surviving patients
Compare the mean duration of hospital stay between the patients surviving in study and control groups
Measured: 28 days from the date of diagnosis / discharge
Secondary outcomes (8)
Mean dose of steroid requirement for surviving patients
Compare the mean total dose of steroid required in between the patients surviving in study and control groups
Measured: 28 days from the date of diagnosis
Mean time to completely wean off from Oxygen (02) supplementation for surviving patients
Compare the mean time to completely wean off from Oxygen supplementation in patients between the patients surviving in study and control groups
Measured: 28 days from the date of diagnosis / discharge
Changes in the biochemical profiles of Interleukin-6 (IL-6)
IL-6 levels in control vs study group patients
Measured: 28 days from the date of diagnosis / discharge
Changes in the biochemical profiles of quantitative C reactive protein (CRP)
Quantitative CRP levels in control vs study group patients
Measured: 28 days from the date of diagnosis / discharge
Changes in the biochemical profiles of D-Dimer
D-Dimer levels in control vs study group patients
Measured: 28 days from the date of diagnosis / discharge
Changes in the biochemical profiles of Ferritin
Ferritin levels in control vs study group patients
Measured: 28 days from the date of diagnosis / discharge
Acute pulmonary toxicities that may be attributable to LDRT
Acute pulmonary toxicities as per the Common Terminology Criteria for Adverse Events (CTCAE) version 5
Measured: 28 days from the date of diagnosis / discharge
Total cost of hospital stay following LDRT for surviving patients
Cost evaluation and comparison between the patients surviving in study and control groups
Measured: 28 days from the date of diagnosis / discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- To explore the role of low dose pulmonary radiotherapy (LDRT) in moderate disease category of COVID-19 patients with pneumonitis in terms of the following primary and secondary objectives. The outcome of LDRT in a pilot group of 10 patients (Study group) would be compared with another 10 patients (Control group) who have not given consent for LDRT and/or would not able to be able to lie down still for the entire treatment duration in the radiotherapy unit. This is not a randomized but a case-control study.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahatma Gandhi Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niloy Ranjan Datta, Mahatma Gandhi Institute of Medical Sciences
- Investigators
- Niloy R Datta, MD,DNB, Principal investigator, Dept of Radiotherapy, Mahatma Gandhi Institute of Medical Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904783
- Sponsor's protocol ID
- MGIMS/IEC/RADTHP/215/2021
- Acronym
- LOCORAD
- Status last verified
- Jul 2021
- First submitted
- 25 May 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Not yet decided. Will decide later after the study results are available
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Radiation Therapy in COVID-19
- ClinicalTrials.gov ID
- NCT04904783
- Acronym / sponsor ID
- LOCORAD / MGIMS/IEC/RADTHP/215/2021
- Keywords
- COVID-19, Pneumonia, Low dose radiotherapy, Cytokine storm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mahatma Gandhi Institute of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot case-control study at Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sevagram, India is designed to evaluate the use of low dose radiotherapy (LDRT) in patients with moderate COVID-19 with specific objectives to abrogate the onset of cytokine storm and thus facilitate their early recovery and reduce mortality.
Detailed description
One of the primary attributes to the mortality in coronavirus disease -19 (COVID-19) is acute respiratory distress syndrome (ARDS) induced by severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) mediated cytokine storm (CS).To mitigate the ARDS, an ideal approach would be to diminish the viral load by activating immune cells for CS prevention or to suppress the overactive cytokine-releasing immune cells. The search for ideal pharmaceutical agent/s to take care of SARS-CoV-2 mediated CS is still eluding the clinicians. The only drugs with modest clinical benefit are remdesivir and dexamethasone. The availability of the former is uncertain while an overdependence on steroids could prove counterproductive as evident from increasing incidence of fatal mucormycosis reported in post-COVID patients treated with steroids. The situation for COVID-19 patients successfully treated with steroids is akin to "from frying pan into the fire".
Thus, concerted efforts are needed to prevent the onset of CS in COVID-19. This, would directly help to lower the mortality. One of the approaches being recently investigated worldwide, is the use of single low dose radiotherapy (LDRT) of 0.5 - 1.5 Gy to the lungs before the onset of CS in moderately affected COVID-19 patients requiring oxygen supplementation. This crucial window of opportunity needs to be exploited with LDRT to mitigate the onset of the fatal CS.
LDRT could thus be a potential game changer in the management of COVID-19. LDRT with its multipronged actions may attenuate immune activation and consequently mitigate the production of pro-inflammatory cytokines. A number of centers have reported encouraging outcomes in pilot studies with LDRT. There has been a significant reduction in oxygen requirement within just 72 hours of LDRT, resulting in reduced hospital stay and deaths. This pilot case-control study at MGIMS is designed to evaluate the use of LDRT in patients with moderate COVID-19 with specific objectives to prevent the onset of CS and thus facilitate their early recovery and reduce mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To explore the role of low dose pulmonary radiotherapy (LDRT) in moderate disease category of COVID-19 patients with pneumonitis in terms of the following primary and secondary objectives. The outcome of LDRT in a pilot group of 10 patients (Study group) would be compared with another 10 patients (Control group) who have not given consent for LDRT and/or would not able to be able to lie down still for the entire treatment duration in the radiotherapy unit. This is not a randomized but a case-control study.
| Arm | Type | Receives |
|---|---|---|
| Study arm | Active comparator | Radiation: Low dose radiotherapy10 patients of confirmed diagnosis of moderate COVID-19 who fulfil the inclusion criteria and give written informed consent would be in study arm. All patients, belong to both study and control groups would receive the same treatment (oxygen support, steroids, anticoagulant therapy, remdesivir and other supportive therapy) as per the Institute guidelines for management of moderate COVID-19 disease. Only low dose radiotherapy would be added to patients in the study arm. |
| Control Arm | No intervention | –10 patients of confirmed diagnosis of moderate COVID-19 who fulfil the inclusion criteria and have not given written informed consent would be in study arm. These patients would receive the same treatment (oxygen support, steroids, anticoagulant therapy, remdesivir and other supportive therapy) as per the Institute guidelines for management of moderate COVID-19 disease except low dose radiotherapy. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Reverse transcription polymerase chain reaction (RT-PCR) / Rapid Ag test positive
- Signed informed consent
- Age ≥ 50 yrs
- Respiratory rate : 25 - 30/min, breathless AND/OR
- Oxygen saturation by pulse oximetry (SpO2) in 90 - 93% on room air (readings taken after 5 mins of stopping oxygen supplementation)
Key exclusion criteria (11 listed)
- Patient who have received vaccination for COVID-19 (single / both doses of any approved vaccine)
- Hemodynamic instability in shock and/or systolic BP < 90mm Hg
- Septicemia
- Disseminated intravascular coagulation
- Requiring ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose radiotherapyPatients in study group will receive LDRT to both lungs by two parallel opposed fields, antero-posterior (AP) and postero-anterior (PA) to deliver a midplane dose of 0.5 Gy in a single fraction. As this dose is very less, doses to the critical structures including heart and lungs would be very low. All the patients will be treated on Telecobalt unit (Theratronics Phoenix, Canada) and not on the linear accelerator to avoid risks to cancer patients on treatment with linear accelerator. CT based plan will not be undertaken for logistic issues and is also not felt to be mandatory for this LDRT. Dose computation would be carried out by manual dose calculation for the Telecobalt unit. | Radiation | Study arm |
Primary outcome
Number of patients dying due to COVID-19
Time frame: 28 days from the date of diagnosis
Compare the number of patients whose death could be ascribed to COVID-19 in the two groups
Mean duration of hospital stay for surviving patients
Time frame: 28 days from the date of diagnosis / discharge
Compare the mean duration of hospital stay between the patients surviving in study and control groups
8 secondary outcomes
Mean dose of steroid requirement for surviving patients
Time frame: 28 days from the date of diagnosis
Mean time to completely wean off from Oxygen (02) supplementation for surviving patients
Time frame: 28 days from the date of diagnosis / discharge
Changes in the biochemical profiles of Interleukin-6 (IL-6)
Time frame: 28 days from the date of diagnosis / discharge
Changes in the biochemical profiles of quantitative C reactive protein (CRP)
Time frame: 28 days from the date of diagnosis / discharge
Changes in the biochemical profiles of D-Dimer
Time frame: 28 days from the date of diagnosis / discharge
Changes in the biochemical profiles of Ferritin
Time frame: 28 days from the date of diagnosis / discharge
Acute pulmonary toxicities that may be attributable to LDRT
Time frame: 28 days from the date of diagnosis / discharge
Total cost of hospital stay following LDRT for surviving patients
Time frame: 28 days from the date of diagnosis / discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: Yes. Not yet decided. Will decide later after the study results are available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niloy R Datta, MD,DNB principal investigator
Dept of Radiotherapy, Mahatma Gandhi Institute of Medical Sciences, India
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose radiotherapy in people with COVID-19 and Pneumonia, run by Mahatma Gandhi Institute of Medical Sciences at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niloy R Datta, MD,DNB (+91- 9717388117, niloydatta@mgims.ac.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients dying due to COVID-19 (time frame: 28 days from the date of diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.