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All Studies   Meta Analysis    Recent:   

The Effect of Early Hydroxychloroquine-based Therapy in COVID-19 Patients in Ambulatory Care Settings: A Nationwide Prospective Cohort Study

Sulaiman et al., medRxiv, doi:10.1101/2020.09.09.20184143
Sep 2020  
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Mortality 64% Improvement Relative Risk Death/ICU 44% ICU admission 37% Hospitalization 39% HCQ for COVID-19  Sulaiman et al.  EARLY TREATMENT Is early treatment with HCQ beneficial for COVID-19? Prospective study of 7,892 patients in Saudi Arabia Lower mortality (p=0.012) and death/ICU (p=0.019) with HCQ c19hcq.org Sulaiman et al., medRxiv, September 2020 FavorsHCQ Favorscontrol 0 0.5 1 1.5 2+
HCQ for COVID-19
1st treatment shown to reduce risk in March 2020
 
*, now with p < 0.00000000001 from 411 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments. c19hcq.org
Observational prospective 5,541 patients, adjusted HCQ mortality odds ratio OR 0.36, p = 0.012. Adjusted hospitalization OR 0.57, p < 0.001. Zinc supplementation was used in all cases. Early treatment in ambulatory fever clinics in Saudi Arabia.
risk of death, 63.7% lower, RR 0.36, p = 0.01, treatment 7 of 1,817 (0.4%), control 54 of 3,724 (1.5%), NNT 94, adjusted per study, odds ratio converted to relative risk.
risk of death/ICU, 44.4% lower, RR 0.56, p = 0.02, treatment 21 of 1,817 (1.2%), control 95 of 3,724 (2.6%), adjusted per study, odds ratio converted to relative risk.
risk of ICU admission, 36.7% lower, RR 0.63, p = 0.13, treatment 14 of 1,817 (0.8%), control 56 of 3,724 (1.5%), adjusted per study, odds ratio converted to relative risk.
risk of hospitalization, 38.6% lower, RR 0.61, p < 0.001, treatment 171 of 1,817 (9.4%), control 617 of 3,724 (16.6%), NNT 14, adjusted per study, odds ratio converted to relative risk.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Sulaiman et al., 13 Sep 2020, prospective, Saudi Arabia, preprint, 22 authors, dosage 400mg bid day 1, 200mg bid days 2-5.
This PaperHCQAll
The Effect of Early Hydroxychloroquine-based Therapy in COVID-19 Patients in Ambulatory Care Settings: A Nationwide Prospective Cohort Study
Tarek Sulaiman, Abdulrhman Mohana, Laila Alawdah, Nagla Mahmoud, Mustafa Hassanein, Tariq Wani, Amel Alfaifi, Eissa Alenazi, Nashwa Radwan, Nasser Alkhalifah, Ehab Elkady, Manwer Alanazi, Mohammed Alqahtani, Khalid Abdullah, Yousif Yousif, Fouad Abogazalah, Fuad Awwad, Khaled Alabdulkareem, Fahad Alghofaili, Ahmad Aljedai, Hani Jokhdar, Fahad Alrabiah
doi:10.1101/2020.09.09.20184143
BACKGROUND: Currently, there is no proven effective therapy nor vaccine for the treatment of SARS-CoV-2. Evidence regarding the potential benefit of early administration of hydroxychloroquine (HCQ) therapy in symptomatic patients with Coronavirus Disease (COVID-19) is not clear. METHODS: This observational prospective cohort study took place in 238 ambulatory fever clinics in Saudi Arabia, which followed the Ministry of Health (MOH) COVID-19 treatment guideline. This guideline included multiple treatment options for COVID-19 based on the best available evidence at the time, among which was Hydroxychloroquine (HCQ). Patients with confirmed COVD-19 (by reverse transcriptase polymerase chain reaction (PCR) test) who presented to these clinics with mild to moderate symptoms during the period from 5-26 June 2020 were included in this study. Our study looked at those who received HCQ-based therapy along with supportive care (SC) and compared them to patients who received SC alone. The primary outcome was hospital admission within 28-days of presentation. The secondary outcome was a composite of intensive care admission (ICU) and/or mortality during the followup period. Outcome data were assessed through a follow-up telephonic questionnaire at day 28 and were further verified with national hospitalisation and mortality registries. Multiple logistic regression model was used to control for prespecified confounders. RESULTS: Of the 7,892 symptomatic PCR-confirmed COVID-19 patients who visited the ambulatory fever clinics during the study period, 5,541 had verified clinical outcomes at day 28 (1,817 patients in the HCQ group vs 3,724 in the SC group). At baseline, patients who received HCQ therapy were more likely to be males who did not have hypertension or chronic lung disease compared to the SC group. No major differences were noted regarding other comorbid conditions. All patients were presenting with active complaints; however, the HCQ groups had higher rates of symptoms compared to the SC group (fever: 84% vs 66.3, headache: 49.8 vs 37.4, cough: 44.5 vs 35.6, respectively). Early HCQ-based therapy was associated with a lower hospital admission within 28-days compared to SC alone (9.4% compared to 16.6%, RRR 43%, p-value <0.001). The composite outcome of ICU admission and/or mortality at 28days was also lower in the HCQ group compared to the SC (1.2% compared to 2.6%, RRR 54%, p-value 0.001). Adjusting for age, gender, and major comorbid conditions, a multivariate logistic regression model showed a decrease in the odds of hospitalisation in patients who received HCQ compared to SC alone (adjusted OR 0.57 [95% CI 0.47-0.69], p-value <0.001). The composite outcome of ICU admission and/or mortality was also lower for the HCQ group All rights reserved. No reuse allowed without permission. perpetuity.
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Evidence ' 'regarding the potential benefit of early administration of hydroxychloroquine (HCQ) therapy ' 'in symptomatic patients with Coronavirus Disease (COVID-19) is not ' 'clear.</jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p>This ' 'observational prospective cohort study took place in 238 ambulatory fever clinics in Saudi ' 'Arabia, which followed the Ministry of Health (MOH) COVID-19 treatment guideline. This ' 'guideline included multiple treatment options for COVID-19 based on the best available ' 'evidence at the time, among which was Hydroxychloroquine (HCQ). Patients with confirmed ' 'COVD-19 (by reverse transcriptase polymerase chain reaction (PCR) test) who presented to ' 'these clinics with mild to moderate symptoms during the period from 5-26 June 2020 were ' 'included in this study. Our study looked at those who received HCQ-based therapy along with ' 'supportive care (SC) and compared them to patients who received SC alone. The primary outcome ' 'was hospital admission within 28-days of presentation. The secondary outcome was a composite ' 'of intensive care admission (ICU) and/or mortality during the follow-up period. Outcome data ' 'were assessed through a follow-up telephonic questionnaire at day 28 and were further ' 'verified with national hospitalisation and mortality registries. Multiple logistic regression ' 'model was used to control for prespecified ' 'confounders.</jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p>Of the ' '7,892 symptomatic PCR-confirmed COVID-19 patients who visited the ambulatory fever clinics ' 'during the study period, 5,541 had verified clinical outcomes at day 28 (1,817 patients in ' 'the HCQ group vs 3,724 in the SC group). At baseline, patients who received HCQ therapy were ' 'more likely to be males who did not have hypertension or chronic lung disease compared to the ' 'SC group. No major differences were noted regarding other comorbid conditions. All patients ' 'were presenting with active complaints; however, the HCQ groups had higher rates of symptoms ' 'compared to the SC group (fever: 84% vs 66.3, headache: 49.8 vs 37.4, cough: 44.5 vs 35.6, ' 'respectively). Early HCQ-based therapy was associated with a lower hospital admission within ' '28-days compared to SC alone (9.4% compared to 16.6%, RRR ' '43%,<jats:italic>p-value</jats:italic>&lt;0.001). The composite outcome of ICU admission ' 'and/or mortality at 28-days was also lower in the HCQ group compared to the SC (1.2% compared ' 'to 2.6%, RRR 54%,<jats:italic>p-value</jats:italic>0.001). Adjusting for age, gender, and ' 'major comorbid conditions, a multivariate logistic regression model showed a decrease in the ' 'odds of hospitalisation in patients who received HCQ compared to SC alone (adjusted OR 0.57 ' '[95% CI 0.47-0.69],<jats:italic>p-value &lt;0.001</jats:italic>). The composite outcome of ' 'ICU admission and/or mortality was also lower for the HCQ group compared to the SC group ' 'controlling for potential confounders (adjusted OR 0.55 [95% CI ' '0.34-0.91],<jats:italic>p-value</jats:italic>0.019).</jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p>Early ' 'intervention with HCQ-based therapy in patients with mild to moderate symptoms at ' 'presentation is associated with lower adverse clinical outcomes among COVID-19 patients, ' 'including hospital admissions, ICU admission, and/or death.</jats:p></jats:sec>', 'DOI': '10.1101/2020.09.09.20184143', 'type': 'posted-content', 'created': {'date-parts': [[2020, 9, 13]], 'date-time': '2020-09-13T13:20:13Z', 'timestamp': 1600003213000}, 'source': 'Crossref', 'is-referenced-by-count': 6, 'title': 'The Effect of Early Hydroxychloroquine-based Therapy in COVID-19 Patients in Ambulatory Care ' 'Settings: A Nationwide Prospective Cohort Study', 'prefix': '10.1101', 'author': [ {'given': 'Tarek', 'family': 'Sulaiman', 'sequence': 'first', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-9646-5635', 'authenticated-orcid': False, 'given': 'Abdulrhman', 'family': 'Mohana', 'sequence': 'additional', 'affiliation': []}, {'given': 'Laila', 'family': 'Alawdah', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nagla', 'family': 'Mahmoud', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mustafa', 'family': 'Hassanein', 'sequence': 'additional', 'affiliation': []}, {'given': 'Tariq', 'family': 'Wani', 'sequence': 'additional', 'affiliation': []}, {'given': 'Amel', 'family': 'Alfaifi', 'sequence': 'additional', 'affiliation': []}, {'given': 'Eissa', 'family': 'Alenazi', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nashwa', 'family': 'Radwan', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nasser', 'family': 'AlKhalifah', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ehab', 'family': 'Elkady', 'sequence': 'additional', 'affiliation': []}, {'given': 'Manwer', 'family': 'Alanazi', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mohammed', 'family': 'Alqahtani', 'sequence': 'additional', 'affiliation': []}, {'given': 'Khalid', 'family': 'Abdullah', 'sequence': 'additional', 'affiliation': []}, {'given': 'Yousif', 'family': 'Yousif', 'sequence': 'additional', 'affiliation': []}, {'given': 'Fouad', 'family': 'AboGazalah', 'sequence': 'additional', 'affiliation': []}, {'given': 'Fuad', 'family': 'Awwad', 'sequence': 'additional', 'affiliation': []}, {'given': 'Khaled', 'family': 'Alabdulkareem', 'sequence': 'additional', 'affiliation': []}, {'given': 'Fahad', 'family': 'AlGhofaili', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ahmad', 'family': 'AlJedai', 'sequence': 'additional', 'affiliation': []}, {'given': 'Hani', 'family': 'Jokhdar', 'sequence': 'additional', 'affiliation': []}, {'given': 'Fahad', 'family': 'Alrabiah', 'sequence': 'additional', 'affiliation': []}], 'member': '246', 'reference': [ { 'key': '2021021605350676000_2020.09.09.20184143v1.1', 'unstructured': 'Notification of 2019-nCoV infection. 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Hydroxychloroquine ' 'in the treatment of outpatients with mildly symptomatic COVID-19: A ' 'multi-center observational study. medRxiv. 2020 Jan 1. doi: ' 'https://doi.org/10.1101/2020.08.20.20178772', 'DOI': '10.1101/2020.08.20.20178772'}], 'container-title': [], 'original-title': [], 'link': [ { 'URL': 'https://syndication.highwire.org/content/doi/10.1101/2020.09.09.20184143', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 11, 18]], 'date-time': '2022-11-18T02:29:08Z', 'timestamp': 1668738548000}, 'score': 1, 'resource': {'primary': {'URL': 'http://medrxiv.org/lookup/doi/10.1101/2020.09.09.20184143'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2020, 9, 13]]}, 'references-count': 31, 'URL': 'http://dx.doi.org/10.1101/2020.09.09.20184143', 'relation': {}, 'published': {'date-parts': [[2020, 9, 13]]}, 'subtype': 'preprint'}
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