---
title: Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01)
nct_id: NCT04435717
overall_status: TERMINATED
phase: PHASE2
sponsor: Hospital Universitario Ramon y Cajal
study_type: INTERVENTIONAL
primary_condition: Covid19
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04435717.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04435717"
ct_last_update_post_date: 2021-08-30
last_seen_at: "2026-05-12T06:02:30.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01)

**Official Title:** Unicenter, Randomized, Open-label Clinical Trial on the Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19

**NCT ID:** [NCT04435717](https://clinicaltrials.gov/study/NCT04435717)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Futility
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 26
- **Lead Sponsor:** Hospital Universitario Ramon y Cajal
- **Conditions:** Covid19
- **Start Date:** 2020-05-04
- **Completion Date:** 2021-02-10
- **CT.gov Last Update:** 2021-08-30

## Brief Summary

unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.

## Detailed Description

National, unicenter, randomized, open-label, controlled phase II clinical trial with a drug marketed and administered under conditions of use other than those approved.

The study is designed to evaluate the effect of adding Tocilizumab to standard or standard of care for patients infected with COVID-19 and diagnosed with mild-moderate pneumonia.

78 patients are expected to be included in the study in a single center in Spain. The study includes a selection and randomization period, and a 28-day follow-up period (or until death, or premature withdrawal, whichever is earlier). Once the patients complete the study, they will continue with their usual follow-up.

## Eligibility

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

```
Inclusion Criteria:

1. Patients over 18 years of age who have given their informed consent. This will be collected verbally and will be recorded in the medical record by the investigating doctor.
2. The patient is diagnosed with mild-moderate SARS-CoV-2 pneumonia confirmed microbiologically ≤7 days before randomization, and presents:

   to. Basal oxygen saturation\> 90% b. CURB-65 ≤1 c. PaO2 / FiO2≥300 or SatO2 / FiO2≥315
3. The patient is hospitalized or meets hospital admission criteria.
4. The patient is not expected to enter the ICU or die in the next 24 hours.

Exclusion Criteria:

1. Participants in another simultaneous clinical trial.
2. Use of other immunomodulators.
3. Coinfection with the hepatitis B virus (detectable AgSup-HBV).
4. Pregnancy (or planning to become pregnant during the course of the study), or lactation period.
5. Presence of laboratory abnormalities of grade ≥ 4.
```

## Arms

- **TCZ 8 mg / kg one dose** (EXPERIMENTAL) — TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment
- **TCZ 8 mg / kg in two** (EXPERIMENTAL) — TCZ 8 mg / kg in two doses at 0 and 12 hours (with a maximum of 800 mg per dose) + usual treatment
- **standard care treatment** (NO_INTERVENTION) — Usual / standard care treatment

## Interventions

- **Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1** (DRUG) — Tocilizumab 20 MG/ML Intravenous (one dose)
- **Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)** (DRUG) — Tocilizumab 20 MG/ML Intravenous ( two doses)

## Primary Outcomes

- **Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.** _(time frame: Day1 and Day3.)_ — Average increase in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.

## Secondary Outcomes

- **Progression of pneumonia** _(time frame: Day3, Day7 and Day28)_
- **PaO2/FiO2** _(time frame: Day3, Day7 and Day28)_
- **cause mortality to 28 days after started treatment** _(time frame: Day3, Day7 and Day28)_
- **Length of hospital stay** _(time frame: Day3, Day7 and Day28)_
- **patients requiring Intensive Care Unit admission** _(time frame: Day3, Day7 and Day28)_
- **evolution of inflammatory parameters IL12** _(time frame: Day0, Day3 and Day7)_
- **evolution of inflammatory parameters IL-10, IL-1, IL-6, IL-17 and IFN-gamma** _(time frame: Day0, Day3 and Day7)_
- **evolution of inflammatory parameters Procalcitonin (PCT),** _(time frame: Day0, Day3 and Day7)_
- **evolution of inflammatory parameters C-reactive protein (PCR),** _(time frame: Day0, Day3 and Day7)_
- **evolution of inflammatory parameters D-dimer** _(time frame: Day0, Day3 and Day7)_
- **evolution of inflammatory parameters and ferritin** _(time frame: Day0, Day3 and Day7)_
- **pharmacokinetics of tocilizumab Cmin** _(time frame: Day0, Day1 Day3 and Day7)_
- **pharmacokinetics of tocilizumab Cmax** _(time frame: days Day0, Day1 Day3 and Day7)_
- **pharmacokinetics of tocilizumab Cmedia** _(time frame: days Day0, Day1 Day3 and Day7)_
- **pharmacokinetics of tocilizumab Tmax** _(time frame: days Day0, Day1 Day3 and Day7)_
- **pharmacokinetics of tocilizumab AUC** _(time frame: days Day0, Day1 Day3 and Day7)_
- **Adverse event** _(time frame: days Day0, Day3, Day7 and Day28)_
- **Adverse event to cause the treatment interruption.** _(time frame: days Day0, Day3, Day7 and Day28)_
- **Adverse event Abnormalities in laboratory** _(time frame: days Day0, Day3, Day7 and Day28)_

## Locations (1)

- Hospital Universitario Ramón y Cajal, Madrid, Spain

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — 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)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital universitario ramón y cajal|madrid||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04435717.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04435717*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*