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

Primary Purpose

COVID19, Hydroxychloroquine, Prophylaxis

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Hydroxychloroquine
Sponsored by
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID19 focused on measuring COVID19, Households, Hydroxychloroquine, prophylaxis, early phase treatment, prevention, asymptomatic, paucisymptomatic, home situation, SARS-CoV-2-exposed subjects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Irst Irccs

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Group 1: Hydroxychloroquine

Group 1: Observation

Group 2: Hydroxycloroquine

Group 2: Observation

Arm Description

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.

observation only

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.

Observation only

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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.
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.
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.
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.
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.

Full Information

First Posted
April 24, 2020
Last Updated
February 11, 2021
Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Collaborators
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT04363827
Brief Title
Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19)
Acronym
PROTECT
Official Title
PROTECT: A Randomized Study With Hydroxychloroquine Versus Observational Support for Prevention or Early Phase Treatment of Coronavirus Disease (COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Collaborators
University of Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19, Hydroxychloroquine, Prophylaxis, Treatment, SARS-CoV-2
Keywords
COVID19, Households, Hydroxychloroquine, prophylaxis, early phase treatment, prevention, asymptomatic, paucisymptomatic, home situation, SARS-CoV-2-exposed subjects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Hydroxychloroquine
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 1: Observation
Arm Type
No Intervention
Arm Description
observation only
Arm Title
Group 2: Hydroxycloroquine
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Observation
Arm Type
No Intervention
Arm Description
Observation only
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Hydroxychloroquine
Primary Outcome Measure Information:
Title
the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization.
Description
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.
Time Frame
within 1 month from randomization
Title
the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.
Description
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.
Time Frame
within 14 days from randomization
Secondary Outcome Measure Information:
Title
The proportion of subjects with positive swabs in Group 1 within 1 month from randomization in both arms
Description
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
Time Frame
within 1 month from randomization
Title
The proportion of subjects of Group 1 who become symptomatic in each arm within 1 month from randomization
Description
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.
Time Frame
within 1 month from randomization
Title
The proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.
Description
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.
Time Frame
within 14 days from randomization
Title
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
Description
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.
Time Frame
within 1 month from randomization
Title
Absolute and relative frequencies of Serious Adverse Events
Description
Absolute and relative frequencies of Serious Adverse Events (CTCAE version 5.0) in both arms for the Group 1 and Group 2.
Time Frame
up to 10 months
Title
Variation in Quality of Life scores in different time points
Description
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.
Time Frame
up to 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Martinelli, Prof.
Organizational Affiliation
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS , Meldola Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pierluigi Viale, Prof.
Organizational Affiliation
Univeristy of Bologna
Official's Role
Study Chair
Facility Information:
Facility Name
Irst Irccs
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
32736597
Citation
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.
Results Reference
derived

Learn more about this trial

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

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