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

NCT04363827 | Terminated Phase 2 DMC

• 1 other identifier: IRST100.47
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  within 14 days from randomization

Secondary Outcomes (6)

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

  within 1 month from randomization

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

  within 1 month from randomization

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

  within 14 days 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

  within 1 month from randomization

• Absolute and relative frequencies of Serious Adverse Events

  up to 10 months

Study Arms (4)

Group 1: Hydroxychloroquine

EXPERIMENTAL

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

Group 1: Observation

NO INTERVENTION

observation only

Group 2: Hydroxycloroquine

EXPERIMENTAL

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

Group 2: Observation

NO INTERVENTION

Observation only

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine

Group 1: Hydroxychloroquine; Group 2: Hydroxycloroquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead
• University of Bologna: collaborator

Study Sites (1)

Irst Irccs

Meldola, FC, 47014, Italy

Location

Related Publications (1)

• 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.

  PMID: 32736597 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 27, 2020
• Study Start: May 14, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

IT (1)