---
title: Ultra Low Doses of Therapy With Radiation Applicated to COVID-19
nct_id: NCT04394182
overall_status: SUSPENDED
phase: NA
sponsor: Fundacion GenesisCare
study_type: INTERVENTIONAL
primary_condition: Pneumonia, Viral
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04394182.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04394182"
ct_last_update_post_date: 2022-03-29
last_seen_at: "2026-05-12T06:11:04.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Ultra Low Doses of Therapy With Radiation Applicated to COVID-19

**Official Title:** Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers

**NCT ID:** [NCT04394182](https://clinicaltrials.gov/study/NCT04394182)

## Key Facts

- **Status:** SUSPENDED
- **Why Stopped:** lack of recruitment
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 15
- **Lead Sponsor:** Fundacion GenesisCare
- **Collaborators:** Hospital La Milagrosa, Hospital Vithas Valencia Consuelo
- **Conditions:** Pneumonia, Viral, Cytokine Storm
- **Start Date:** 2020-04-21
- **Completion Date:** 2022-03-21
- **CT.gov Last Update:** 2022-03-29

## Brief Summary

The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients.

In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose \< 1 Gy.

The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.

## Detailed Description

The exceedingly high mortality rates of severe and critical COVID-19 warrant the evaluation of novel therapies that could potentially mitigate the advanced disease manifestations. In this context, is proposes a prospective multicenter study. It will include 15 patients, to assess the feasibility and efficacy of low-dose lung irradiation in COVID-19 pneumonia.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 120 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Age \> 18 years-old.
2. Diagnosis of pneumonia due to COVID-19 serologically proven by polymerase chain reaction (PCR) or highly suspected to be COVID-related.
3. Charlson Comorbidity Index (CCI) less than 6 score.
4. Poor or no response to standard medical treatment, based on:

   \*% Sat02 \<93%
   * Oxygen therapy escalation (Understanding from less to more need for support: Nasal Cannula-NC-; Ventimask -VMK- and VMK with reservoir)
   * Pa02 / Fi02 (blood gas analysis) \<300 mmHg
   * 1 or more inflammatory and immunological analytical parameters such as lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen with values above the normal range, except lymphocytes.
   * Radiological impairment defined as worsening of TSS throughout admission or score at admission: TSS\> 5 by a diagnostic baseline CT scan.
5. Eastern Cooperative Oncology Group (ECOG) Status \< or = 3
6. Life expectancy (LE)\> 1 month at hospital admission for COVID-19
7. No previous thoracic RT (relative-individualization criteria) or chemotherapy (chemoinduced pulmonary toxicity, eg Bleomycin).
8. Verbal information on the procedure, objective and secondary effects, acceptance and signing of informed consent by the patient or legal guardian.

Exclusion Criteria:

* Failure to meet the inclusion criteria.
* Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator.
* Patients admitted in ICU.
* Refusal of treatment after verbal information.
```

## Arms

- **An experimental group receiving radiotherapy** (EXPERIMENTAL) — an experimental group with a poor or no response to standard medical treatment and without invasive mechanical ventilation (IMV) will receive ultra low-dose lung radiotherapy (0.8 Gy single dose)

## Interventions

- **Ultra-Low-dose radiotherapy** (RADIATION) — The total dose to be administered was 0.8 Gy in an only single session including both whole-lungs extended 1cm isometric in all directions.
- **ventilatory support with oxygen therapy** (DEVICE) — Oxygen Therapy: Nasal Cannula (NC); Ventimask (VMK) or VMK with reservoir
- **Lopinavir/ritonavir** (DRUG) — 100/400 mg/12h; 7-10 days
- **Hydroxychloroquine** (DRUG) — 200 mg/12h
- **Azithromycin** (DRUG) — 500 mg/24h, 3 days
- **Piperacillin/tazobactam** (DRUG) — 4 g / 0.5 g administered every 6-8 hours through a vein (directly into the bloodstream), for 5-14 days. Adjustment to kidney function
- **Low molecular weight heparin** (DRUG) — prophylactic doses
- **Corticosteroid injection** (DRUG) — 250mg x 3 boluses
- **Tocilizumab** (DRUG) — 600mg single dose

## Primary Outcomes

- **Oxygen Therapy Status at Day 2** _(time frame: At 2 after RT)_ — To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir \>VMK \>Nasal Cannula-(NC).)
- **Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 2** _(time frame: At 2 days after RT)_ — To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy \>93% (Pulse oximeter measurement)

## Secondary Outcomes

- **Blood Gas Analysis at Day 2** _(time frame: At 2 days after RT)_
- **Blood Test at Day 2** _(time frame: At 2 days after RT)_
- **Oxygen Therapy Status at Day 5** _(time frame: At 5 after RT)_
- **Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 5** _(time frame: At 5 days after RT)_
- **Blood Test at Day 5** _(time frame: At 5 days after RT)_
- **Oxygen Therapy Status at Day 7** _(time frame: At 7 after RT)_
- **Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 7** _(time frame: At 7 days after RT)_
- **Blood Test at Day 7** _(time frame: At 7 days after RT)_
- **Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan at Day 7** _(time frame: At 7 days after RT)_
- **Recovery time** _(time frame: From RT administration until hospital discharge or death)_
- **COVID-19 status** _(time frame: At 7 days after RT)_
- **Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan al Month 1** _(time frame: At 1 month after RT)_
- **Acute Toxicity** _(time frame: 1-3 months after RT)_

## Locations (2)

- Hospital La Milagrosa, GenesisCare, Madrid, Spain
- Hospital Vithas Valencia Consuelo, Valencia, Spain

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital la milagrosa, genesiscare|madrid||spain` — added _(2026-05-12)_
- `locations.hospital vithas valencia consuelo|valencia||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04394182.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04394182*  
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