Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
21 febbraio 2021 aggiornato da: Tim Richard Edmund Harris, Hamad Medical Corporation
Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Reducing viral load is potentially key to reducing viral transmission between humans.
Observational data suggests HC and AZ may reduce the viral load.
In this study we will randomise ambulatory patients with Covid 19 (confirmed by PCR in combination with clinical symptoms) to receive HC/AZ or HC/placebo or placebo for 7 days.
On days 2-14, participants will be reviewed by a member of the research team and samples will be obtained for viral load, an ECG recorded and physical examination performed.
On days 15-20, participants will be reviewed by telephone using a semi structured questionnaire.
On day 21 participants will be examined in person and an oronasopharyngeal swabs obtained for PCR analysis.
Participants will be followed for 6 months via their medical records.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
456
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
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Doha, Qatar, 3050
- Hamad Medical Corporation
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Patient is in HMC facility for low-acuity, Covid-positive patients being quarantined.
- Positive Covid test on qualitative assay used during routine care (i.e. not as part of Q-PROTECT)
- Age at least 18
Exclusion Criteria:
- Treating physician judges patient not appropriate for study participation for any reason
- Age <18
- Breastfeeding or pregnancy (patient-reported pregnancy status is sufficient)
- Hypersensitivity to chloroquine or HC or AZ
History of or known QT prolongation
- EKG required before study entry and on each visit during the subject's first seven days on pro-tocol, during the time period HC is being taken
- Baseline QTc >480 if QRS width normal; QTc >510 if QRS >120
- Known G6PD deficiency, porphyria, or retinopathy (eye exam prior to study entry)
- Known hepatic or renal disease (or abnormality on liver or renal function testing at study day 1)
- Low magnesium or low potassium (by testing on day 1)
- Current (pre-study) therapy with antimalarial or dapsone
- Current (pre-study) therapy with antiviral agents (e.g. oseltamivir)
Tisdale36 score exceeding 6 as tallied below (based on ACC recommendations)*
- 1 point each: age>67, female sex, or being on loop diuretic
- 2 points each: serum potassium <3.6, QTc>449, acute myocardial infarction
- 3 points each: sepsis, heart failure, QT-prolonging drugs
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Combination therapy group
hydroxychloroquine 200mg TID for 7 days plus Azithromycin 500mg OD 1st day and 250 from day 2 to 5
|
Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days
Altri nomi:
Azithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
Altri nomi:
|
|
Comparatore attivo: Monotherapy therapy group
hydroxychloroquine 200mg TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
|
Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days
Altri nomi:
Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
|
|
Comparatore placebo: Control group
Placebo Cap TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
|
Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
Oral, one tablet three times a day for 7 days
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of virologically cured (PCR-negative status) as assessed on day six
Lasso di tempo: Day 6
|
Days
|
Day 6
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
virologic cure on other study days
Lasso di tempo: Day14 and Day 21
|
Days
|
Day14 and Day 21
|
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virologic semiquantitative analysis of changing viral load
Lasso di tempo: Day 1 to Day 21
|
Days
|
Day 1 to Day 21
|
|
proportion of initially symtomatic subjects with disappearance of clinical symptoms
Lasso di tempo: Day14 and Day 21
|
Days
|
Day14 and Day 21
|
|
proportion of initially asymtomatic subjects with appearance of new clinical symptoms
Lasso di tempo: Day14 and Day 21
|
Days
|
Day14 and Day 21
|
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proportions of subjects with potentially medication- related adverse events
Lasso di tempo: 7 day
|
grades
|
7 day
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Tim R Harris, Hamad Medical Corporation
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
14 aprile 2020
Completamento primario (Effettivo)
14 agosto 2020
Completamento dello studio (Effettivo)
30 agosto 2020
Date di iscrizione allo studio
Primo inviato
12 aprile 2020
Primo inviato che soddisfa i criteri di controllo qualità
14 aprile 2020
Primo Inserito (Effettivo)
16 aprile 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 febbraio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 febbraio 2021
Ultimo verificato
1 febbraio 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni da coronavirus
- Infezioni da Coronaviridae
- Infezioni da Nidovirus
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni delle vie respiratorie
- Malattie delle vie respiratorie
- Polmonite, virale
- Polmonite
- Malattie polmonari
- COVID-19
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Inibitori enzimatici
- Agenti antireumatici
- Agenti antibatterici
- Agenti antiprotozoici
- Agenti antiparassitari
- Antimalarici
- Azitromicina
- Idrossiclorochina
Altri numeri di identificazione dello studio
- MRC-05-001
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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