NCT04420390: LOWRAD-Cov19

Low Dose Radiotherapy for COVID-19 Pneumonitis

Status unknown NA Last updated 9 June 2020

What this trial tests

NA trial testing Radiotherapy in Covid19 in 41 participants. Status unknown.

Timeline

1 May 2020

Primary endpoint
31 July 2020

8 September 2020

Quick facts

Lead sponsor	Hospital San Carlos, Madrid
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	1 May 2020
Primary completion	31 July 2020
Estimated completion	8 September 2020
Sites	1 location across Spain

Drugs / interventions tested

• Radiotherapy — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Hospital San Carlos, Madrid

Who can join

60 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

SARS-CoV-2 is causing an unprecedented stress on healthcare systems around the world, due to its high rate of infection and the high morbidity and mortality.

The COVID-19 infection triggers an inflammatory cascade with cytokine synthesis, prompting the immune response. Low dose radiotherapy (LD-RT) (≤ 100 cGy) induces an anti-inflammatory response, lowering levels of pro-inflammatory cytokines such as IL-1β or inhibit leukocyte recruitment. LD-RT has been used historically for the pneumonia treatment reporting a rapid clinical improvement (within the first week), as well as a reduced mortality (from around 30% to 10%). Considering these results, LD-RT can potentially afford a therapeutic benefit against SARS-CoV-2. The study purpose is to evaluate prospectively the safety and efficacy of LD-RT for SARS-CoV-2.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Low-Dose Radiation Therapy (LDRT) for COVID-19: Benefits or Risks?
   Prasanna PG, Woloschak GE, DiCarlo AL, Buchsbaum JC, et al · · 2020 · cited 37× · PMID 33045077 · DOI 10.1667/rade-20-00211.1
2. Could pulmonary low-dose radiation therapy be an alternative treatment for patients with COVID-19 pneumonia? Preliminary results of a multicenter SEOR-GICOR nonrandomized prospective trial (IPACOVID trial).
   Arenas M, Algara M, De Febrer G, Rubio C, et al · · 2021 · cited 21× · PMID 34230996 · DOI 10.1007/s00066-021-01803-3
3. The risk of induced cancer and ischemic heart disease following low dose lung irradiation for COVID-19: estimation based on a virtual case.
   Arruda GV, Weber RRDS, Bruno AC, Pavoni JF. · · 2021 · cited 14× · PMID 33164596 · DOI 10.1080/09553002.2021.1846818
4. Low-dose Radiation Therapy in the Management of COVID-19 Pneumonia (LOWRAD-Cov19). Final results of a prospective phase I-II trial.
   Sanmamed N, Alcantara P, Gómez S, Bustos A, et al · · 2022 · cited 8× · PMID 35367528 · DOI 10.1016/j.radonc.2022.03.015
5. COVID-19: The Disease, the Immunological Challenges, the Treatment with Pharmaceuticals and Low-Dose Ionizing Radiation.
   Yu J, Azzam EI, Jadhav AB, Wang Y. · · 2021 · cited 5× · PMID 34571861 · DOI 10.3390/cells10092212
6. Low-dose radiation therapy for coronavirus disease-2019 pneumonia: Is it time to look beyond apprehensions?
   Pandey BN. · · 2020 · cited 5× · PMID 33381234 · DOI 10.4103/atm.atm_433_20
7. [Low dose radiotherapy for COVID-19 pneumopathy: Biological rationale and literature review].
   Miran C, Bonnet É, Allignet B, Clippe S, et al · · 2021 · PMID 33903009 · DOI 10.1016/j.canrad.2021.03.005
8. Low dose radiotherapy for COVID pneumonia: Irradiate to Eradicate - Will it be possible?
   Deokar K, Shadrach BJ, Chawla G, Asfahan S, et al · · 2020 · PMID 33682811 · DOI 10.23750/abm.v92i1.10369