Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
21 février 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
456
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Doha, Qatar, 3050
- Hamad Medical Corporation
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
Azithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
Autres noms:
|
|
Comparateur actif: 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
Autres noms:
Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
|
|
Comparateur 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of virologically cured (PCR-negative status) as assessed on day six
Délai: Day 6
|
Days
|
Day 6
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
virologic cure on other study days
Délai: Day14 and Day 21
|
Days
|
Day14 and Day 21
|
|
virologic semiquantitative analysis of changing viral load
Délai: Day 1 to Day 21
|
Days
|
Day 1 to Day 21
|
|
proportion of initially symtomatic subjects with disappearance of clinical symptoms
Délai: Day14 and Day 21
|
Days
|
Day14 and Day 21
|
|
proportion of initially asymtomatic subjects with appearance of new clinical symptoms
Délai: Day14 and Day 21
|
Days
|
Day14 and Day 21
|
|
proportions of subjects with potentially medication- related adverse events
Délai: 7 day
|
grades
|
7 day
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Tim R Harris, Hamad Medical Corporation
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
14 avril 2020
Achèvement primaire (Réel)
14 août 2020
Achèvement de l'étude (Réel)
30 août 2020
Dates d'inscription aux études
Première soumission
12 avril 2020
Première soumission répondant aux critères de contrôle qualité
14 avril 2020
Première publication (Réel)
16 avril 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 février 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 février 2021
Dernière vérification
1 février 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Infections à coronavirus
- Infections à Coronaviridae
- Infections à Nidovirales
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Pneumonie virale
- Pneumonie
- Maladies pulmonaires
- COVID-19 [feminine]
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Inhibiteurs d'enzymes
- Agents antirhumatismaux
- Agents antibactériens
- Agents antiprotozoaires
- Agents antiparasitaires
- Antipaludéens
- Azithromycine
- Hydroxychloroquine
Autres numéros d'identification d'étude
- MRC-05-001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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