PROTECT: studio randomizzato con idrossiclorochina vs osservazione per la prevenzione e il trattamento precoce della malattia da coronavirus (COVID-19)

PROTECT: A randomized study with Hydroxychloroquine versus observational support for prevention or early phase treatment of Coronavirus disease (COVID-19). - PROTECT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001501-24-IT

Enrollment

2300

Registered

2020-06-24

Start date

2020-04-28

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Group 1: SARS-CoV-2-exposed subjects, as household members/contacts of COVID-19 patients Group 2: Patients with COVID-19 asymptomatic or paucisymptomatic in home situation MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862

Interventions

Product Name: IDROSSICLOROCHINA_IRSTIRCCS Product Code: [IDROSSICLOROCHINA_IRSTIRCCS] Pharmaceutical Form: Coated tablet INN or Proposed INN: IDROSSICLOROCHINA SOLFATO CAS Number: 118-42-3 Current Spo

Eligibility

Sex/Gender

All

Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500

Exclusion criteria

Exclusion criteria: 1) Reported anamnesis for: a. Intolerance or previous toxicity for hydroxychloroquine/chloroquine b. Bradycardia or reduction rhythm of heart with arrythmias c. Ischemic heart disease d. Retinopathy e. Congestive heart failure under/with use of diuretics f. Favism or glucose-6-phosphate dehydrogenase (G6PD) deficiency g. Diabetes type 1 h. Major comorbidities like advanced chronic kidney disease or dialysis therapy, known history of ventricular arrhythmias, any oncologic/hematologic malignancy. i. 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) Known positiveness for HIV, active HCV, HBV infection 6) Subject with a positive test for SARS-CoV-2 (for Group 1) 7) Pregnant or lactating 8) Current use of medications with known significant drug-drug interactions: digoxin, hypoglycemic agents, anticonvulsant, Cyclosporine, Phenylbutazone, drugs that inhibit CYP2D6 9) Known prolonged QT syndrome or current use of drugs with known QT prolungation 10) Participation in another clinical trial with any investigational agents within 30 days prior to study screening.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To compare the efficacy of Hydroxychloroquine: - as prophylaxis, in prevention of COVID-19 infection in a population of SARS-CoV-2-exposed subjects (household members/contacts of COVID-19 pts) respect to observation only - as prophylaxis, in subgroup population (stratification factors, class of age, gender) - in early phase COVID-19 pts within 14 days from randomization in subgroup population (stratification factors, class of age, gender) - in early phase COVID-19 pts within 1 month from randomization in overall population and in subgroup population (stratification factors, class of age, gender) To evaluate in study groups: - treatment toxicity - QoL To participate in European network for meta analysis of similar studies or in data collection for identifying prediction rule of outcomes. Explorative: To identify biologic features that correlate with susceptibility or resistance to SARs-CoV2 infection or treatment with Hydroxychloroquine in study subgroups.;Primary end point(s): Group 1: the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization Group 2: the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization;Timepoint(s) of evaluation of this end point: 4 months;Main Objective: Group 1: Prevention of COVID-19 or related symptoms in SARS-CoV-2-exposed subjects, as household members/contacts of COVID-19 patients within one month from randomization Group 2: Efficacy of Hydroxychloroquine in early phase COVID-19 within 14 days from randomization	—

Measure

Time frame

Secondary Objective: To compare the efficacy of Hydroxychloroquine: - as prophylaxis, in prevention of COVID-19 infection in a population of SARS-CoV-2-exposed subjects (household members/contacts of COVID-19 pts) respect to observation only - as prophylaxis, in subgroup population (stratification factors, class of age, gender) - in early phase COVID-19 pts within 14 days from randomization in subgroup population (stratification factors, class of age, gender) - in early phase COVID-19 pts within 1 month from randomization in overall population and in subgroup population (stratification factors, class of age, gender) To evaluate in study groups: - treatment toxicity - QoL To participate in European network for meta analysis of similar studies or in data collection for identifying prediction rule of outcomes. Explorative: To identify biologic features that correlate with susceptibility or resistance to SARs-CoV2 infection or treatment with Hydroxychloroquine in study subgroups.;Primary end point(s): Group 1: the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization Group 2: the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization;Timepoint(s) of evaluation of this end point: 4 months;Main Objective: Group 1: Prevention of COVID-19 or related symptoms in SARS-CoV-2-exposed subjects, as household members/contacts of COVID-19 patients within one month from randomization Group 2: Efficacy of Hydroxychloroquine in early phase COVID-19 within 14 days from randomization

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Secondary

Measure	Time frame
Secondary end point(s): Variation in Quality of Life scores in different time points (weekly) respect to baseline values in both Group 1 and Group 2 populations.; Absolute and relative frequencies of Serious Adverse Events (CTCAE version 5.0) in both arms for the Group 1 and Group 2.; To participate in European network for meta-analysis of similar studies or in data collection for identifying prediction rule of outcomes.; Explorative Objective; To identify biologic features that correlate with susceptibility or resistance to SARS-CoV-2 infection or treatment with Hydroxychloroquine in a subgroup of household members/contacts of COVID-19 patients or COVID-19 patients enrolled.; 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, 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 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 identified by stratification factors, class of age and gender.;Timepoint(s) of evaluation of this end point: 10 months; 10 months; 10 months; 10 months; 4 monts; 4 monts; 4 monts; 4 months	—

Measure

Time frame

Secondary end point(s): Variation in Quality of Life scores in different time points (weekly) respect to baseline values in both Group 1 and Group 2 populations.; Absolute and relative frequencies of Serious Adverse Events (CTCAE version 5.0) in both arms for the Group 1 and Group 2.; To participate in European network for meta-analysis of similar studies or in data collection for identifying prediction rule of outcomes.; Explorative Objective; To identify biologic features that correlate with susceptibility or resistance to SARS-CoV-2 infection or treatment with Hydroxychloroquine in a subgroup of household members/contacts of COVID-19 patients or COVID-19 patients enrolled.; 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, 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 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 identified by stratification factors, class of age and gender.;Timepoint(s) of evaluation of this end point: 10 months; 10 months; 10 months; 10 months; 4 monts; 4 monts; 4 monts; 4 months

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Countries

Italy

Contacts

Public ContactCentro di Coordinamento Studi IRST

ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI - IRST IRCCS - MELDOLA (FC)

cc.ubsc@irst.emr.it0544285330

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026