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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04363827
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : June 2, 2020
Sponsor:
Collaborator:
University of Bologna
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Brief 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 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).


Condition or disease Intervention/treatment Phase
COVID19 Hydroxychloroquine Prophylaxis Treatment SARS-CoV-2 Drug: Hydroxychloroquine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PROTECT: A Randomized Study With Hydroxychloroquine Versus Observational Support for Prevention or Early Phase Treatment of Coronavirus Disease (COVID-19)
Actual Study Start Date : May 14, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Experimental: Group 1: Hydroxychloroquine
A 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.
Drug: Hydroxychloroquine
Hydroxychloroquine

No Intervention: Group 1: Observation
observation only
Experimental: Group 2: Hydroxycloroquine
A 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.
Drug: Hydroxychloroquine
Hydroxychloroquine

No Intervention: Group 2: Observation
Observation only



Primary Outcome Measures :
  1. 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 ]
    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.

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


Secondary Outcome Measures :
  1. The proportion of subjects with positive swabs in Group 1 within 1 month from randomization in both arms [ Time Frame: within 1 month from randomization ]
    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

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

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

  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 [ Time Frame: within 1 month from randomization ]
    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.

  5. Absolute and relative frequencies of Serious Adverse Events [ Time Frame: up to 10 months ]
    Absolute and relative frequencies of Serious Adverse Events (CTCAE version 5.0) in both arms for the Group 1 and Group 2.

  6. Variation in Quality of Life scores in different time points [ Time Frame: up to 10 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or Female, aged >= 18 years
  2. 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

  3. COVID-19 patients, asymptomatic or paucisymptomatic in home situation who are not in treatment with any anti COVID-19 medication (Group 2)
  4. Absence of any COVID-19 symptom in last week before randomization (fever >37.5°C, cough, dyspnea) (only for group 1 subjects)
  5. Paracetamol treatment is accepted only for group 2.
  6. 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.

Exclusion Criteria:

  1. Reported anamnesis for:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363827


Contacts
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Contact: Oriana Nanni +390543739266 oriana.nanni@irst.emr.it
Contact: Giovanni Martinelli, Prof. giovanni.martinelli@irst.emr.it

Locations
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Italy
Irst Irccs Recruiting
Meldola, FC, Italy, 47014
Contact: Giovanni Martinelli, Prof       giovanni.martinelli@irst.emr.it   
Sponsors and Collaborators
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
University of Bologna
Investigators
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Study Chair: Giovanni Martinelli, Prof. Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS , Meldola Italy
Study Chair: Pierluigi Viale, Prof. Univeristy of Bologna
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Responsible Party: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier: NCT04363827    
Other Study ID Numbers: IRST100.47
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori:
COVID19
Households
Hydroxychloroquine
prophylaxis
early phase treatment
prevention
asymptomatic
paucisymptomatic
home situation
SARS-CoV-2-exposed subjects
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents