AzTrials
AzTrials

Pneumonitis, InterstitialPhase 2TOFACoV-2NCT04390061

TOFAcitinib Plus Hydroxycloroquine vs Hydroxycloroquine in Patients With COVID-19 Interstitial Pneumonia

A Phase 2 study testing Tofacitinib and Hydroxychloroquine in people with Pneumonitis, Interstitial and COVID-19, run by Università Politecnica delle Marche.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Multifocal interstitial pneumonia represents the most common cause of admission in intensive care units and death in SARS-CoV2 infections. In our Hospital, similarly to what reported in literature, up to 25% of admitted patients with pneumonitis requires mechanical ventilation or oro-tracheal intubation within 5-10… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pneumonitis, Interstitial, COVID-19
What is being tested?
Tofacitinib and Hydroxychloroquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
No sites listed yet
Study dates
Jun 2020to Oct 2020
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • SARS-CoV2 Infection diagnosed by rt-PCR
  • CT-scan confirmed interstitial pneumonia
  • Hospital admission from less than 24h
  • P/F ratio >150 mmHg
  • Written Informed Consent

Who cannot join

  • Age <18 ys or >65
  • Patients in mechanical ventilation at time of admission
  • Severe Hearth failure (NYHA 3 or 4)
  • QTc > 470 ms or >500 ms in wide QRS patients
  • Severe History of Chronic Ischemic Heart Disease, defined as history of Major Adverse Cardiovascular Event and/or recent (one year) revascularization.
  • History of recurrent Deep Venous Thrombosis and Pulmonary Embolism or established thrombophilic conditions (e.g. history of anti-phospholipid antibodies, …)
Show all 24Show fewer
  • Active Bacterial or Fungal Infection
  • Hematological cancer
  • Metastatic or intractable cancer
  • Pre-existent neurodegenerative disease
  • Severe Hepatic Impairment,
  • History of acute diverticular disease or intestinal perforation
  • HBsAg positive and/or HBV-DNA positive patients
  • Severe Renal Failure (Creatinine Clearance <30ml/h)
  • Active Herpes zoster infection
  • Patients with active or latent TB
  • Severe anemia (Hb<9g/dl)
  • Lymphocyte count below 750/mcl
  • Neutrophil count below 1000/mcl
  • Platelet count below 50000/mcl
  • Pregnancy or Lactation
  • History of intolerance to the experimental drugs or excipients
  • Degenerative maculopathy or other relevant retinal disease
  • Inability to give informed consent (severe transitory or permanent mental impairment, incapacitation)

Trial locations and contacts

No sites are listed yet.

Armando Gabrielli, MD contact

0712206104

a.gabrielli@staff.univpm.it

About this study

Official title: TOFAcitinib Plus Hydroxycloroquine vs Hydroxycloroquine in Patients With Early Onset SARS-CoV2 (COVID-19) Interstitial Pneumonia:a Multicenter Randomized Controlled Open Label Trial

Multifocal interstitial pneumonia represents the most common cause of admission in intensive care units and death in SARS-CoV2 infections. In our Hospital, similarly to what reported in literature, up to 25% of admitted patients with pneumonitis requires mechanical ventilation or oro-tracheal intubation within 5-10 days. No established treatment is available for this condition. Preliminary evidence is accumulating about the efficacy of an aggressive treatment of the corona virus-induced inflammation and, in particular, investigators believe that blocking JAK1 is clinically rewarding in down-regulating IL-6 driven inflammation in patients with corona-virus infection. Thus, investigators designed a randomized controlled trial to test the hypothesis that adding Tofacitinib to the standard treatment in the early phase of COVID related pneumonitis could prevent the development of severe respiratory failure needing mechanical ventilation.

Being tested
Tofacitinib, Hydroxychloroquine
Medical subject headings
Lung Diseases, Interstitial, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04390061
Study groupRoleWhat they receive
tofacitinib+HYQExperimentalTofacitinib 10mg cp twice a day + Hydroxychloroquine 200mg cp three times a day, both for 14 days
Receives: Drug: Tofacitinib; Drug: Hydroxychloroquine
HydroxychloroquineActive comparatorHydroxychloroquine 200mg cp three times a day for 14 days
Receives: Drug: Hydroxychloroquine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevention of severe Respiratory Failure requiring mechanical ventilation

    Rate of patients needing mechanical ventilation to maintain PaO2/FIO2>150

    Measured: 14 days

Secondary outcomes (4)

  1. Prevention of need of ICU admission

    Rate of patients needing admission to the intensive care unit

    Measured: 28 days

  2. Prevention of COVID-19 related Deaths

    Rate of patients who die due to COVID-19 related conditions

    Measured: 28 days

  3. Identification of predictors of outcome

    Role of some clinical and laboratory factors in predicting outcome (Age, sex, smoking status, Body Mass Index (BMI), Comorbidities (Diabetes, number of comorbidities), Respiratory Failure at admission defined as PaO2/FiO2<300, Extension of Ct-scan involvement, basal level of serum IL-6, vW-Factor, Thrombomodulin, KL-6, sACE2 and SP-D )

    Measured: 14 days

  4. Incidence of Treatment-Emergent Adverse Events

    Rate of severe drug-related adverse events

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2020
  2. Study startJun 2020 (estimated)
  3. Primary completionSep 2020 (estimated)
  4. Study completionOct 2020 (estimated)

Resources

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
Model description
Multicenter open label randomized controlled trial
Masking
None (open label)
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04390061
Sponsor's protocol ID
2020-002035-30
Acronym
TOFACoV-2
Status last verified
May 2020
First submitted
13 May 2020
Last updated
15 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tofacitinib and Hydroxychloroquine in people with Pneumonitis, Interstitial and COVID-19, run by Università Politecnica delle Marche.

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 24 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 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.

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 Armando Gabrielli, MD (0712206104, a.gabrielli@staff.univpm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevention of severe Respiratory Failure requiring mechanical ventilation (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04390061.

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 15 May 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in