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COVID19Phase 2PROTECTNCT04363827

Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19)

A Phase 2 study testing Hydroxychloroquine in people with COVID19 and Hydroxychloroquine, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a Italian, superiority, open label cluster-randomised, interventional clinical trial aimed at assessing whether the treatment with Hydroxychloroquine can reduce the percentage of symptomatic subjects compared to observation only in household members/contacts of COVID-19 patients (Group 1) and if the treatment… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID19, Hydroxychloroquine, Prophylaxis
What is being tested?
Hydroxychloroquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
1 siteItaly
Study dates
14 May 2020to 30 Sep 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or Female, aged >= 18 years
  • SARS-CoV-2-exposed subjects, as household members and/or contacts of COVID-19 patients (Group 1). In this group are included Health care professionals in contact with COVID-19 patients.
  • or
  • COVID-19 patients, asymptomatic or paucisymptomatic in home situation who are not in treatment with any anti COVID-19 medication (Group 2)
  • Absence of any COVID-19 symptom in last week before randomization (fever >37.5°C, cough, dyspnea) (only for group 1 subjects)
  • Paracetamol treatment is accepted only for group 2.
  • Participant is willing and able to give informed consent for participation in the study (either recorded during a telephonic interview or signed in person) and agrees with the study and its conduct.

Who cannot join

  • Reported anamnesis for:
  • Intolerance or previous toxicity for hydroxychloroquine/chloroquine
  • Bradycardia or reduction rhythm of heart with arrythmias
  • Ischemic heart disease
  • Retinopathy
  • Congestive heart failure under/with use of diuretics
Show all 18Show fewer
  • Favism or glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Diabetes type 1
  • Major comorbidities like advanced chronic kidney disease or dialysis therapy, known history of ventricular arrhythmias, any oncologic/hematologic malignancy.
  • Severe neurological and mental illness
  • Any other contraindication to take hydroxychloroquine
  • Already taking chloroquine, hydroxychloroquine or analogous during the past 3 weeks
  • Use of other antiviral agents in the last 3 weeks
  • Subject with a positive test for SARS-CoV-2 (for Group 1)
  • Pregnant or lactating
  • Current use of medications with known significant drug-drug interactions: digoxin, hypoglycemic agents, anticonvulsant, Cyclosporine, Phenylbutazone, drugs that inhibit CYP2D6
  • Known prolonged QT syndrome or current use of drugs with known QT prolongation
  • Participation in another clinical trial with any investigational agents within 30 days prior to study screening.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Irst Irccs

    Meldola, FC, 47014

Other trials in Italy

About this study

Official title: PROTECT: A Randomized Study With Hydroxychloroquine Versus Observational Support for Prevention or Early Phase Treatment of Coronavirus Disease (COVID-19)

This is a Italian, superiority, open label cluster-randomised, interventional clinical trial aimed at assessing whether the treatment with Hydroxychloroquine can reduce the percentage of symptomatic subjects compared to observation only in household members/contacts of COVID-19 patients (Group 1) and if the treatment with Hydroxychloroquine could be introduced in early phase COVID-19 population (Group 2).

The participants will be randomised to receive either:

Arm A) hydroxychloroquine vs Arm B) Observation (2:1 randomisation).

Read the detailed description

This is an open label, superiority, cluster-randomized Italian interventional clinical trial, evaluating the role of Hydroxychloroquine versus observation only in preventing infection to COVID-19 or treating early phase COVID-19 patients.

Each index case is randomised to either Arm A: Hydroxychloroquine or Arm B: observation in a 2:1 ratio on an open label basis. Participants in the same cluster receive the same intervention.

Study population is constituted by:

Group 1: Severe Acute Respiratory Syndrome (SARS) - Corona Virus (CoV)-2-exposed subjects , as household members/contacts of COVID-19 patients.

Group 2: Patients with COVID-19 asymptomatic or paucisymptomatic in home situation.

Being tested
Hydroxychloroquine
Keywords
COVID19, Households, Hydroxychloroquine, prophylaxis, early phase treatment, prevention, asymptomatic, paucisymptomatic, home situation, SARS-CoV-2-exposed subjects
Medical subject headings
COVID-19

What participants receive

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

Study groups in NCT04363827
Study groupRoleWhat they receive
Group 1: HydroxychloroquineExperimentalA loading dose Hydroxychloroquine 400 mg twice daily at day 1, followed by a weekly dose of Hydroxychloroquine 200 mg twice daily on days 8, 15 and 22, covering a total of 1 month of treatment.
Receives: Drug: Hydroxychloroquine
Group 1: ObservationNo interventionobservation only
Group 2: HydroxycloroquineExperimentalA loading dose Hydroxychloroquine 400 mg twice daily at day 1 followed by 200 mg twice daily for a total of at least 5-7 days according to clinical evolution.
Receives: Drug: Hydroxychloroquine
Group 2: ObservationNo interventionObservation only

What is being measured

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

  1. the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization.

    Group 1:The primary endpoint/outcome measure is the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization.

    Measured: within 1 month from randomization

  2. the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.

    Group 2: The primary endpoint/outcome measure is the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.

    Measured: within 14 days from randomization

Secondary outcomes (6)

  1. The proportion of subjects with positive swabs in Group 1 within 1 month from randomization in both arms

    The proportion of subjects with positive swabs in randomized population of SARS-CoV-2-exposed subjects ( Group 1) within 1 month from randomization in both arms

    Measured: within 1 month from randomization

  2. The proportion of subjects of Group 1 who become symptomatic in each arm within 1 month from randomization

    The proportion of subjects of Group 1 who become symptomatic in each arm within 1 month from randomization, in subgroup population identified by stratification factors, class of age and gender.

    Measured: within 1 month from randomization

  3. The proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.

    The proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization, in subgroup population identified by stratification factors, class of age and gender.

    Measured: within 14 days from randomization

  4. The proportion of subjects of Group 2 who become swab negative in each arm within 1 month from randomization in overall population and in subgroup population

    The proportion of subjects of Group 2 who become swab negative in each arm within 1 month from randomization in overall population and in subgroup population identified by stratification factors, class of age and gender.

    Measured: within 1 month from randomization

  5. Absolute and relative frequencies of Serious Adverse Events

    Absolute and relative frequencies of Serious Adverse Events (CTCAE version 5.0) in both arms for the Group 1 and Group 2.

    Measured: up to 10 months

  6. Variation in Quality of Life scores in different time points

    Variation in Quality of Life scores EQ-5D-5L (EQ-5D descriptive system with 5 severity levels from better to worse, and the EQ visual analogue scale (EQ VAS, scale from 100 to 0, high is better) in different time points (weekly) respect to baseline values in both Group 1 and Group 2 populations.

    Measured: up to 10 months

Timeline

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

  1. First posted27 Apr 2020
  2. Study start14 May 2020
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Why it stopped: Difficulties in recruiting subjects were observed soon after the study was initiated. This difficulty was attributed to the decreased incidence of infections which occurred in the period following the first lock down.

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
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04363827
Sponsor's protocol ID
IRST100.47
Acronym
PROTECT
Status last verified
Mar 2025
First submitted
24 Apr 2020
Last updated
10 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nanni O, Viale P, Vertogen B, Lilli C, Zingaretti C, Donati C, Masini C, Monti M, Serra P, Vespignani R, Grossi V, Biggeri A, Scarpi E, Galardi F, Bertoni L, Colamartini A, Falcini F, Altini M, Massa I, Gaggeri R, Martinelli G. PROTECT Trial: A cluster-randomized study with hydroxychloroquine versus observational support for prevention or early-phase treatment of Coronavirus disease (COVID-19): A structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Jul 31;21(1):689. doi: 10.1186/s13063-020-04527-4.

    PubMed 32736597

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hydroxychloroquine in people with COVID19 and Hydroxychloroquine, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.

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 7 inclusion and 18 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: stopped early, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

The study was stopped early (reason given: Difficulties in recruiting subjects were observed soon after the study was initiated. This difficulty was attributed to the decreased incidence of infections which occurred in the period following the first lock down.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization. (time frame: within 1 month from randomization). 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?

On the ClinicalTrials.gov record for NCT04363827, which also lists 1 linked publication.

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 10 Mar 2025.

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