COVID-19Phase 2TOCOVIDNCT04332094
Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)
A Phase 2 study testing Tocilizumab, Hydroxychloroquine and Azithromycin in people with COVID-19, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 7 sites in Spain.
Trial summary
COVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality. Currently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Tocilizumab, Hydroxychloroquine and Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 7 sitesSpain
- Study dates
- 2 Apr 2020to Jul 2021
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject (or authorized legal representative) who can provide written informed consent before beginning any study procedure.
- Understand and agree to abide by the study procedures.
- Adult #18 years of age at the time of inclusion in the study.
- Confirmation of SARS-CoV-2 infection by a microbiological test performed before randomization, no longer than 72 hours.
- Severity 3-4 according to the WHO 7-point ordinal scale.
Who cannot join
- ALT / AST> 5 times the normal limit
- Stage 4 chronic kidney disease (GFR <30) or requiring dialysis.
- Presence of comorbidities that imply a poor prognosis (according to clinical judgment).
- Advanced dementia.
- Pregnancy or breastfeeding.
- Anticipation of transfer to another center in the 12 hours at the beginning of the study.
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- Allergy to study medication.
- Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2.
- Streptococcus pneumoniae antigenuria positive before study start.
- Neutropenia <500 / mm3.
- Thrombocytopenia <100,000 / mm3.
- History of diverticulosis.
- Ongoing skin infection (eg, pyodermitis).
- Transplanted patient under immunosuppressive treatment.
- Previous evidence of latent untreated tuberculosis.
Trial locations and contacts
7 sites in 1 country.
Pere Domingo, MD, PhD contact
7 sites in 1 country
Spain7 sites, 7 recruiting
- Recruiting
Hospital General Universitario de Alicante
Alicante, Valencia
Esperanza Merino
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Pere Domingo, MD, PhD, pdomingo@santpau.cat
Pere Domingo, MD, PhD
- Recruiting
Hospital del Mar
Barcelona
Juan Pablo Horcajada
- Recruiting
Hospital Sant Joan Despí
Barcelona
Ana Coloma
- Recruiting
Hospital General Universitario de Elche
Elche, Valencia
Felix Gutierrez
- Recruiting
Hospital Clinico San Carlos
Madrid
Vicente Estrada
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias
Victor Asensi
About this study
Official title: Pilot, Randomized, Multicenter, Open-label Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)
COVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality.
Currently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. This clinical trial is designed to evaluate the use of Tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with COVID-19.
- Conditions
- COVID-19
- Being tested
- Tocilizumab, Hydroxychloroquine, Azithromycin
- Keywords
- Tocilizumab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
162 mg sc x 2 doses + tocilizumab 162mg sc x 2 doses at 12 hours (day 1)
400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)
AzithromycinDrug
500 mg / day v.o. for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Early administration of tocilizumab associated with hydroxychloroquine and azithromycin. Receives: Drug: Tocilizumab; Drug: Hydroxychloroquine; Drug: Azithromycin |
| Control | Active comparator | Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin. Receives: Drug: Hydroxychloroquine; Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: Through hospitalization, an average of 2 weeks
Need for mechanical ventilation in the Intensive Care Unit
Measured: Through hospitalization, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start2 Apr 2020
- Primary completionJun 2021 (estimated)
- Study completionJul 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.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332094
- Sponsor's protocol ID
- IIBSP-COV-2020-23
- Acronym
- TOCOVID
- Status last verified
- May 2021
- First submitted
- 31 Mar 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Randomized, Multicenter, Open-label Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)
- ClinicalTrials.gov ID
- NCT04332094
- Acronym / sponsor ID
- TOCOVID / IIBSP-COV-2020-23
- Conditions
- COVID-19
- Keywords
- Tocilizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 2 Apr 2020 (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.
COVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality.
Currently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. This clinical trial is designed to evaluate the use of Tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Tocilizumab, Drug: Hydroxychloroquine, Drug: AzithromycinEarly administration of tocilizumab associated with hydroxychloroquine and azithromycin. |
| Control | Active comparator | Drug: Hydroxychloroquine, Drug: AzithromycinTreatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject (or authorized legal representative) who can provide written informed consent before beginning any study procedure.
- Understand and agree to abide by the study procedures.
- Adult #18 years of age at the time of inclusion in the study.
- Confirmation of SARS-CoV-2 infection by a microbiological test performed before randomization, no longer than 72 hours.
- Severity 3-4 according to the WHO 7-point ordinal scale.
Key exclusion criteria (15 listed)
- ALT / AST> 5 times the normal limit
- Stage 4 chronic kidney disease (GFR <30) or requiring dialysis.
- Presence of comorbidities that imply a poor prognosis (according to clinical judgment).
- Advanced dementia.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Tocilizumab162 mg sc x 2 doses + tocilizumab 162mg sc x 2 doses at 12 hours (day 1) | Drug | Intervention |
| Hydroxychloroquine400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total) | Drug | Control, Intervention |
| Azithromycin500 mg / day v.o. for 3 days | Drug | Control, Intervention |
Primary outcome
In-hospital mortality
Time frame: Through hospitalization, an average of 2 weeks
Need for mechanical ventilation in the Intensive Care Unit
Time frame: Through hospitalization, an average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
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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.
Pere Domingo, MD, PhD contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocilizumab, Hydroxychloroquine and Azithromycin in people with COVID-19, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 7 sites in Spain.
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 5 inclusion and 15 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 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Pere Domingo, MD, PhD (pdomingo@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: Through hospitalization, an average of 2 weeks). 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 6 May 2021.