Similar incidence of Coronavirus Disease 2019 (COVID-19) in patients with rheumatic diseases with and without hydroxychloroquine therapy

Macias et al., medRxiv, doi:10.1101/2020.05.16.20104141, May 2020
Hospitalization 26% improvement lower risk ← → higher risk Case -49% HCQ for COVID-19  Macias et al.  PROPHYLAXIS Is pre-exposure prophylaxis with HCQ beneficial for COVID-19? Retrospective 722 patients in Spain More cases with HCQ (not stat. sig., p=0.53) c19early.org Macias et al., medRxiv, May 2020 0 0.5 1 1.5 2+ RR
HCQ for COVID-19
1st treatment shown to reduce risk in March 2020, now with p < 0.00000000001 from 424 studies, used in 59 countries.
Lower risk for mortality, hospitalization, progression, recovery, cases, and viral clearance.
No treatment is 100% effective. Protocols combine treatments.
6,200+ studies for 200+ treatments. c19early.org
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Very small retrospective study of rheumatic disease patients, sample size is too small for statistical significance (HCQ 0.5-4.0%, no-HCQ 0.4-2.7%). Confirmed cases were 1 HCQ and 2 no-HCQ, confirmed+likely cases were 1 HCQ and 3 no-HCQ. 1 HCQ and 2 no-HCQ patients were admitted to hospital. We do not think a conclusion can be drawn based on these sample sizes.
There are very significant differences between the groups, for example 30% of the HCQ group have SLE vs. 2.5% of the no-HCQ group. SLE patients have a 5.7 times relative risk of pneumonia according to1, whereas the relative risk with glucocorticoids and TNF-α inhibitors is significantly lower2. Two more recent studies with rheumatic disease/autoimmune condition patients provide higher confidence.
Although the 26% lower hospitalization is not statistically significant, it is consistent with the significant 16% lower hospitalization [7‑24%] from meta analysis of the 69 hospitalization results to date.
This study is excluded in the after exclusion results of meta analysis: not fully adjusting for the baseline risk differences within systemic autoimmune patients.
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risk of hospitalization, 25.5% lower, RR 0.74, p = 1.00, treatment 1 of 290 (0.3%), control 2 of 432 (0.5%), NNT 846.
risk of case, 49.0% higher, RR 1.49, p = 0.53, treatment 5 of 290 (1.7%), control 5 of 432 (1.2%).
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Macias et al., 16 May 2020, retrospective, database analysis, Spain, preprint, 12 authors.
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org November 2025 Spain United Kingdom Russia Sudan Angola Colombia Kenya Mozambique Vietnam Peru Philippines China Uzbekistan Nepal Ethiopia Iran Ghana Mexico South Korea Germany Bangladesh Saudi Arabia Algeria Morocco Yemen Poland India DR Congo Madagascar Thailand Uganda Venezuela Nigeria Egypt Bolivia Taiwan Zambia Fiji Georgia Switzerland Bosnia-Herzegovina Ukraine Côte d'Ivoire Bulgaria Greece Slovakia Singapore Iceland New Zealand Czechia Mongolia Israel Trinidad and Tobago Hong Kong North Macedonia Belarus Qatar Panama Serbia CAR Spain favored high-profit treatments.The average efficacy of treatments was very low.High-cost protocols reduce early treatment, andforgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
$0 $500 $1,000+ Efficacy vs. cost for COVID-19treatment protocols worldwide c19early.org November 2025 Spain United Kingdom Russia Sudan Angola Colombia Kenya Mozambique Vietnam Peru Philippines China Uzbekistan Nepal Ethiopia Iran Ghana Mexico South Korea Germany Bangladesh Saudi Arabia Algeria Morocco Yemen Poland India DR Congo Madagascar Thailand Uganda Venezuela Nigeria Egypt Bolivia Taiwan Zambia Fiji Georgia Switzerland Bosnia-Herzegovina Ukraine Côte d'Ivoire Eritrea Bulgaria Greece Slovakia Singapore New Zealand Malawi Czechia Mongolia Israel Trinidad and Tobago North Macedonia Belarus Qatar Panama Serbia Syria Spain favored high-profit treatments.The average efficacy was very low.High-cost protocols reduce early treatment,and forgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
Similar incidence of Coronavirus Disease 2019 (COVID-19) in patients with rheumatic diseases with and without hydroxychloroquine therapy
Juan Macias, Paz Gonzalez-Moreno, Esther Sanchez-Garcia, Ramon Morillo-Verdugo, Carmen Dominguez-Quesada, RPH Ana Pinilla, Mamar Macho, Mavictoria Martinez, Alejandro Gonzalez-Serna, Anais Corma, PhD Luis Miguel Real, MD, PhD Juan Antonio Pineda
doi:10.1101/2020.05.16.20104141
Background: Hydroxychloroquine is currently being tested as post-exposure prophylaxis against coronavirus disease 2019 (COVID-19) in several ongoing clinical trials. Objective: To compare the incidence of COVID-19 in Spanish patients with autoimmune rheumatic diseases treated with and without hydroxychloroquine. Methods: Retrospective electronic record review, from February 27 th to April 16 th , of patients with autoimmune inflammatory diseases followed at two academic tertiary care hospitals in Seville, Spain. The cumulative incidence of COVID-19, confirmed or suspected, was compared between patients with and without hydroxychloroquine as part of their treatment of autoimmune inflammatory diseases. Results: Among 722 included subjects, 290 (40%) were receiving hydroxychloroquine. During the seven-week study period, five (1.7% [95% CI: 0.5%-4.0%] cases of COVID-19 were registered among patients with hydroxychloroquine and five (1.2% [0.4%-2.7%]) (p=0.523) in without hydroxychloroquine. COVID-19 was confirmed by PCR in one (0.3%, 95% CI 0.008-1.9%) patient with hydroxychloroquine and two (0.5%, 95% CI 0.05%-1.6%) without hydroxychloroquine (p=1.0). One patient on hydroxychloroquine and two subjects without hydroxychloroquine were admitted to the hospital, none of them required to be transferred to the intensive care unit and no patient died during the episode. Conclusions: The incidence and severity of COVID-19 among patients with autoimmune rheumatic diseases with and without hydroxychloroquine was not significantly different. Hydroxychloroquine does not seem to be an appropriate therapy for post-exposure prophylaxis against COVID-19.
References
Chowdhury, Rathod, Gernsheimer, A Rapid Systematic Review of Clinical Trials Utilizing Chloroquine and Hydroxychloroquine as a Treatment for COVID-19, Acad Emerg Med, doi:10.1111/acem.14005
Gautret, Lagier, Parola, Hoang, Meddeb et al., Clinical and microbiological effect of a combination of hydroxychloroquine and azithromycin in 80 COVID-19 patients with at least a six-day follow up: A pilot observational study, Travel Med Infect Dis, doi:10.1016/j.tmaid.2020.101663
Haberman, Chen, Castillo, Adhikari, Hundesman, Covid-19 in immune-mediated inflammatory diseases -Case series from New York, New Engl J Med, doi:10.1056/NEJMc2009567
Lai, Wang, Wang, Hsueh, Ko et al., Global epidemiology of coronavirus disease 2019: disease incidence, daily cumulative index, mortality, and their association with country healthcare resources and economic status, Int J Antimicrob Agents
Mitjà, Clotet, Use of antiviral drugs to reduce COVID-19, Lancet Glob Health, doi:10.1016/52214-109X(20)30114-5
Yao, Ye, Zhang, Cui, Huang et al., Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Clin Infect Dis, doi:10.1093/cid/ciaa237
DOI record: { "DOI": "10.1101/2020.05.16.20104141", "URL": "http://dx.doi.org/10.1101/2020.05.16.20104141", "abstract": "<jats:p>Background: Hydroxychloroquine is currently being tested as post-exposure prophylaxis against coronavirus disease 2019 (COVID-19) in several ongoing clinical trials.\nObjective: To compare the incidence of COVID-19 in Spanish patients with autoimmune rheumatic diseases treated with and without hydroxychloroquine.\nMethods: Retrospective electronic record review, from February 27th to April 16th, of patients with autoimmune inflammatory diseases followed at two academic tertiary care hospitals in Seville, Spain. The cumulative incidence of COVID-19, confirmed or suspected, was compared between patients with and without hydroxychloroquine as part of their treatment of autoimmune inflammatory diseases.\nResults: Among 722 included subjects, 290 (40%) were receiving hydroxychloroquine. During the seven-week study period, five (1.7% [95% CI: 0.5%-4.0%] cases of COVID-19 were registered among patients with hydroxychloroquine and five (1.2% [0.4%-2.7%]) (p=0.523) in without hydroxychloroquine. COVID-19 was confirmed by PCR in one (0.3%, 95% CI 0.008-1.9%) patient with hydroxychloroquine and two (0.5%, 95% CI 0.05%-1.6%) without hydroxychloroquine (p=1.0). One patient on hydroxychloroquine and two subjects without hydroxychloroquine were admitted to the hospital, none of them required to be transferred to the intensive care unit and no patient died during the episode.\nConclusions: The incidence and severity of COVID-19 among patients with autoimmune rheumatic diseases with and without hydroxychloroquine was not significantly different. Hydroxychloroquine does not seem to be an appropriate therapy for post-exposure prophylaxis against COVID-19.</jats:p>", "accepted": { "date-parts": [ [ 2020, 5, 20 ] ] }, "author": [ { "ORCID": "http://orcid.org/0000-0002-4778-790X", "affiliation": [], "authenticated-orcid": false, "family": "Macias", "given": "Juan", "sequence": "first" }, { "affiliation": [], "family": "Gonzalez-Moreno", "given": "Paz", "sequence": "additional" }, { "affiliation": [], "family": "Sanchez-Garcia", "given": "Esther", "sequence": "additional" }, { "affiliation": [], "family": "Morillo-Verdugo", "given": "Ramon", "sequence": "additional" }, { "affiliation": [], "family": "Dominguez-Quesada", "given": "Carmen", "sequence": "additional" }, { "affiliation": [], "family": "Pinilla", "given": "Ana", "sequence": "additional" }, { "affiliation": [], "family": "Macho", "given": "MaMar", "sequence": "additional" }, { "affiliation": [], "family": "Martinez", "given": "MaVictoria", "sequence": "additional" }, { "affiliation": [], "family": "Gonzalez-Serna", "given": "Alejandro", "sequence": "additional" }, { "affiliation": [], "family": "Corma", "given": "Anais", "sequence": "additional" }, { "affiliation": [], "family": "Real", "given": "Luis Miguel", "sequence": "additional" }, { "affiliation": [], "family": "Pineda", "given": "Juan Antonio", "sequence": "additional" } ], "container-title": [], "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2020, 5, 20 ] ], "date-time": "2020-05-20T20:21:37Z", "timestamp": 1590006097000 }, "deposited": { "date-parts": [ [ 2021, 6, 25 ] ], "date-time": "2021-06-25T20:29:18Z", "timestamp": 1624652958000 }, "group-title": "Infectious Diseases (except HIV/AIDS)", "indexed": { "date-parts": [ [ 2024, 3, 1 ] ], "date-time": "2024-03-01T23:11:23Z", "timestamp": 1709334683052 }, "institution": [ { "name": "medRxiv" } ], "is-referenced-by-count": 3, "issued": { "date-parts": [ [ 2020, 5, 20 ] ] }, "link": [ { "URL": "https://syndication.highwire.org/content/doi/10.1101/2020.05.16.20104141", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "246", "original-title": [], "posted": { "date-parts": [ [ 2020, 5, 20 ] ] }, "prefix": "10.1101", "published": { "date-parts": [ [ 2020, 5, 20 ] ] }, "publisher": "Cold Spring Harbor Laboratory", "reference-count": 0, "references-count": 0, "relation": { "is-preprint-of": [ { "asserted-by": "subject", "id": "10.1371/journal.pone.0249036", "id-type": "doi" } ] }, "resource": { "primary": { "URL": "http://medrxiv.org/lookup/doi/10.1101/2020.05.16.20104141" } }, "score": 1, "short-title": [], "source": "Crossref", "subject": [], "subtitle": [], "subtype": "preprint", "title": "Similar incidence of Coronavirus Disease 2019 (COVID-19) in patients with rheumatic diseases with and without hydroxychloroquine therapy", "type": "posted-content" }
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