COVID19 Clinical Trial
— PROTECTOfficial title:
PROTECT: A Randomized Study With Hydroxychloroquine Versus Observational Support for Prevention or Early Phase Treatment of Coronavirus Disease (COVID-19)
Verified date | February 2021 |
Source | Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 2300 |
Est. completion date | September 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Irst Irccs | Meldola | FC |
Lead Sponsor | Collaborator |
---|---|
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori | University of Bologna |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | within 1 month from randomization | |
Secondary | 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. | within 1 month from randomization | |
Secondary | 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. | within 14 days from randomization | |
Secondary | 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. | within 1 month from randomization | |
Secondary | 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. | up to 10 months | |
Secondary | 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. | up to 10 months |
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