dh9wm8pg

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?:abstract	BACKGROUND: Hydroxychloroquine (HC) ± azithromycin (AZ) is widely used for Covid-19. The Qatar Prospective RCT of Expediting Coronavirus Tapering (Q-PROTECT) aimed to assess virologic cure rates of HC±AZ in cases of low-acuity Covid-19. METHODS: Q-PROTECT employed a prospective, placebo-controlled design with blinded randomization to three parallel arms: placebo, oral HC (600 mg daily for one week), or oral HC plus oral AZ (500 mg day one, 250 mg daily on days two through five). At enrollment, non-hospitalized participants had mild or no symptoms and were within a day of Covid-19 positivity by polymerase chain reaction (PCR). After six days, intent-to-treat (ITT) analysis of the primary endpoint of virologic cure was assessed using binomial exact 95% confidence intervals (CIs) and χ(2) testing. (ClinicalTrials.gov NCT04349592, trial status closed to new participants.) FINDINGS: The study enrolled 456 participants (152 in each of three groups: HC+AZ, HC, placebo) between 13 April and 1 August 2020. HC+AZ, HC, and placebo groups had 6 (3·9%), 7 (4·6%), and 9 (5·9%) participants go off study medications before completing the medication course (p = 0·716). Day six PCR results were available for all 152 HC+AZ participants, 149/152 (98·0%) HC participants, and 147/152 (96·7%) placebo participants. Day six ITT analysis found no difference (p = 0·821) in groups’ proportions achieving virologic cure: HC+AZ 16/152 (10·5%), HC 19/149 (12·8%), placebo 18/147 (12·2%). Day 14 assessment also showed no association (p = 0·072) between study group and viral cure: HC+AZ 30/149 (20·1%,), HC 42/146 (28·8%), placebo 45/143 (31·5%). There were no serious adverse events. INTERPRETATION: HC±AZ does not facilitate virologic cure in patients with mild or asymptomatic Covid-19. FUNDING: The study was supported by internal institutional funds of the Hamad Medical Corporation (government health service of the State of Qatar).
is ?:annotates of	<https://research.tib.eu/covid-19/entity/dh9wm8pg_hasAnnotation_C0013227> <https://research.tib.eu/covid-19/entity/dh9wm8pg_hasAnnotation_C0206655> <https://research.tib.eu/covid-19/entity/dh9wm8pg_hasAnnotation_C1457887>
?:creator	<https://research.tib.eu/covid-19/entity/Omrani%2C_Ali_S.%3B_Pathan%2C_Sameer_A.%3B_Thomas%2C_Sarah_A.%3B_Harris%2C_Tim_R.E.%3B_Coyle%2C_Peter_V.%3B_Thomas%2C_Caroline_E.%3B_Qureshi%2C_Isma%3B_Bhutta%2C_Zain_A.%3B_Mawlawi%2C_Naema_Al%3B_Kahlout%2C_Reham_Al%3B_Elmalik%2C_Ashraf%3B_Azad%2C_Aftab_M.%3B_Daghfal%2C_Joanne%3B_Mustafa%2C_Mulham%3B_Jeremijenko%2C_Andrew%3B_Soub%2C_Hussam_Al%3B_Khattab%2C_Mohammed_Abu%3B_Maslamani%2C_Muna_Al%3B_Thomas%2C_Stephen_H.>
?:doi	10.1016/j.eclinm.2020.100645
?:doi	<https://research.tib.eu/covid-19/entity/10.1016/j.eclinm.2020.100645>
?:journal	EClinicalMedicine
?:license	no-cc
?:pdf_json_files	document_parses/pdf_json/a684be6371c3e7e6c0e58bffca49751d22e26573.json
?:pmc_json_files	document_parses/pmc_json/PMC7678437.xml.json
?:pmcid	<https://research.tib.eu/covid-19/entity/PMC7678437>
?:pmid	<https://research.tib.eu/covid-19/entity/33251500.0>
?:pmid	33251500.0
?:publication_isRelatedTo_Disease	<https://research.tib.eu/covid-19/entity/COVID-19>
is ?:relation_isRelatedTo_publication of	<https://research.tib.eu/covid-19/entity/dh9wm8pg_HAS_C0052796_TREATS_C5203670>
?:sha_id	<https://research.tib.eu/covid-19/entity/a684be6371c3e7e6c0e58bffca49751d22e26573>
?:source	Elsevier; Medline; PMC
?:title	Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19
?:type	<https://research.tib.eu/covid-19/vocab/Publication>
?:year	2020-11-20

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Value

?:abstract

BACKGROUND: Hydroxychloroquine (HC) ± azithromycin (AZ) is widely used for Covid-19. The Qatar Prospective RCT of Expediting Coronavirus Tapering (Q-PROTECT) aimed to assess virologic cure rates of HC±AZ in cases of low-acuity Covid-19. METHODS: Q-PROTECT employed a prospective, placebo-controlled design with blinded randomization to three parallel arms: placebo, oral HC (600 mg daily for one week), or oral HC plus oral AZ (500 mg day one, 250 mg daily on days two through five). At enrollment, non-hospitalized participants had mild or no symptoms and were within a day of Covid-19 positivity by polymerase chain reaction (PCR). After six days, intent-to-treat (ITT) analysis of the primary endpoint of virologic cure was assessed using binomial exact 95% confidence intervals (CIs) and χ(2) testing. (ClinicalTrials.gov NCT04349592, trial status closed to new participants.) FINDINGS: The study enrolled 456 participants (152 in each of three groups: HC+AZ, HC, placebo) between 13 April and 1 August 2020. HC+AZ, HC, and placebo groups had 6 (3·9%), 7 (4·6%), and 9 (5·9%) participants go off study medications before completing the medication course (p = 0·716). Day six PCR results were available for all 152 HC+AZ participants, 149/152 (98·0%) HC participants, and 147/152 (96·7%) placebo participants. Day six ITT analysis found no difference (p = 0·821) in groups’ proportions achieving virologic cure: HC+AZ 16/152 (10·5%), HC 19/149 (12·8%), placebo 18/147 (12·2%). Day 14 assessment also showed no association (p = 0·072) between study group and viral cure: HC+AZ 30/149 (20·1%,), HC 42/146 (28·8%), placebo 45/143 (31·5%). There were no serious adverse events. INTERPRETATION: HC±AZ does not facilitate virologic cure in patients with mild or asymptomatic Covid-19. FUNDING: The study was supported by internal institutional funds of the Hamad Medical Corporation (government health service of the State of Qatar).

is ?:annotates of