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All Studies   Meta Analysis    Recent:   

Safety and Efficacy of Hydroxychloroquine for Treatment of Non-Severe COVID-19 in Adults in Uganda: A Randomized Open Label Phase II Clinical Trial

Byakika-Kibwika et al., Research Square, doi:10.21203/rs.3.rs-506195/v1
Jun 2021  
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Recovery time 0% Improvement Relative Risk Improvement in Ct value 29% Viral clearance -3% Viral clearance (b) -7% HCQ  Byakika-Kibwika et al.  LATE TREATMENT  RCT Is late treatment with HCQ beneficial for COVID-19? RCT 105 patients in Uganda (October - December 2020) No significant difference in outcomes seen c19hcq.org Byakika-Kibwika et al., Research Square, Jun 2021 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 417 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,800+ studies for 102 treatments. c19hcq.org
Small 105 patient RCT in Uganda showing no significant differences. No mortality was reported. The patients were very young (median age 32), recovering in a median time of 3 days with standard of care, so there is little room for a treatment to make improvements. Time since symptom onset is not specified, but the distribution of symptoms at baseline suggests that the enrollment is relatively late within a cohort of low risk patients.
Viral load measured by PCR may not accurately reflect infectious virus measured by viral culture. Porter et al. show that viral load early in infection was correlated with infectious virus, but viral load late in infection could be high even with low or undetectable infectious virus. Assessing viral load later in infection may underestimate reductions in infectious virus with treatment.
recovery time, no change, relative time 1.00, p = 0.91, treatment 36, control 29.
relative improvement in Ct value, 29.3% better, RR 0.71, p = 0.47, treatment 15, control 15.
risk of no viral clearance, 2.6% higher, RR 1.03, p = 1.00, treatment 35 of 55 (63.6%), control 31 of 50 (62.0%), day 6.
risk of no viral clearance, 6.7% higher, RR 1.07, p = 0.85, treatment 27 of 55 (49.1%), control 23 of 50 (46.0%), day 10.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Byakika-Kibwika et al., 4 Jun 2021, Randomized Controlled Trial, Uganda, preprint, 17 authors, study period October 2020 - December 2020.
This PaperHCQAll
Safety and Efficacy of Hydroxychloroquine for Treatment of Non-Severe COVID-19 in Adults in Uganda: A Randomized Open Label Phase II Clinical Trial
Pauline Byakika-Kibwika, Christine Sekaggya-Wiltshire, Jerome Roy Semakula, Jane Nakibuuka, Joseph Musaazi, James Kayima, Cornelius Sendagire, David Meya, Bruce Kirenga, Sarah Nanzigu, Arthur Kwizera, Fred Nakwagala, Ivan Kisuule, Misaki Wayengera, Henry G Mwebesa, Moses Kamya, William Bazeyo
doi:10.21203/rs.3.rs-506195/v1
Background Several repurposed drugs such as hydroxychloroquine (HCQ) have been investigated for treatment of COVID-19, but none was con rmed to be e cacious. While in vitro studies have demonstrated antiviral properties of HCQ, data from clinical trials were con icting regarding its bene t for COVID-19 treatment. Drugs that limit viral replication may be bene cial in the earlier course of the disease thus slowing progression to severe and critical illness. Design We conducted a randomized open label Phase II clinical trial from October -December 2020. Methods Patients diagnosed with COVID-19 using RT-PCR were included in the study if they were 18 years and above and had a diagnosis of COVID-19 made in the last 3 days. Patients were randomized in blocks, to receive either HCQ 400mg twice a day for the rst day followed by 200mg twice daily for the next 4 days plus standard of care (SOC) treatment or SOC treatment alone. SARS COV-2 viral load using nasal/orapharyngeal swabs was performed at baseline, day 2, 4, 6, 8 and 10. The primary outcome was median time from randomization to SARS COV-2 viral clearance by day 6. Results Of the 105 participants enrolled, 55 were assigned to the intervention group (HCQ plus SOC) and 50 to the control group (SOC only). Baseline characteristics were similar across treatment arms. Viral clearance did not differ by treatment arm, 20 and 19 participants respectively had SARS COV-2 viral load clearance by day 6 with no signi cant difference, median (IQR) number of days to viral load clearance between the two groups was 4(3-4) vs 4(2-4): p=0.457. There were no signi cant differences in secondary outcomes (symptom resolution and adverse events) between the intervention group and the control group. There were no signi cant differences in speci c adverse events such as elevated alkaline phosphatase, prolonged QTc interval on ECG, among patients in the intervention group as compared to the control group. Conclusion Our results show that HCQ 400mg twice a day for the rst day followed by 200mg twice daily for the next 4 days was safe but not associated with reduction in viral clearance or symptom resolution.
Table 3: Baseline clinical and laboratory features There were no signi cant differences in adverse events such as elevated alkaline phosphatase and prolonged QTc interval among patients in the intervention group and control group. Details of clinically signi cant laboratory abnormalities are as shown in Table 6 . (RESCLEAR/05) and the National Drug Authority (CTA 0143). Written informed consent was obtained from all study participants and the trial was conducted according to Good Clinical Practice Guidelines in accordance with the Declaration of Helsinki. Consent for publication Not applicable Competing interests: The authors declare no con ict of interest for this work. Authors' contributions All authors made substantial contributions to trial conception and design. PBK and CSW led the data collection team, JM performed the data analysis. All authors reviewed and interpreted the data, took part in drafting and review of the manuscript and agreed to submit to the current journal; gave nal approval of the version to be published; and agree to be accountable for all aspects of the work.
References
Abella, Jolkovsky, Biney, E cacy and Safety of Hydroxychloroquine vs Placebo for Pre-exposure SARS-CoV-2 Prophylaxis Among Health Care Workers: A Randomized Clinical Trial, JAMA Intern Med, doi:10.1001/jamainternmed.2020.6319
Barnabas, Brown, Bershteyn, Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection : A Randomized Trial, Ann Intern Med, doi:10.7326/M20-6519
Boulware, Pullen, Bangdiwala, A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19, N Engl J Med, doi:10.1056/NEJMoa2016638
Cavalcanti, Zampieri, Rosa, Hydroxychloroquine with or without Azithromycin in Mildto-Moderate Covid-19, N Engl J Med, doi:10.1056/NEJMoa2019014
Chen, Liu, Liu, A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19
Consortium, Whost, Pan, Peto, Repurposed Antiviral Drugs for Covid-19 -Interim WHO Solidarity Trial Results, N Engl J Med, doi:10.1056/NEJMoa2023184
De Wilde, Jochmans, Posthuma, Screening of an FDA-approved compound library identi es four small-molecule inhibitors of Middle East respiratory syndrome coronavirus replication in cell culture, Antimicrob Agents Chemother, doi:10.1128/AAC.03011-14
Dhibar, Arora, Kakkar, Post-exposure prophylaxis with hydroxychloroquine for the prevention of COVID-19, a myth or a reality? The PEP-CQ Study, Int J Antimicrob Agents, doi:10.1016/j.ijantimicag.2020.106224
Fantini, Scala, Chahinian, Structural and molecular modelling studies reveal a new mechanism of action of chloroquine and hydroxychloroquine against SARS-CoV-2 infection, Int J Antimicrob Agents, doi:10.1016/j.ijantimicag.2020.105960
Food, Request for Emergency Use Authorization For Use of Chloroquine Phosphate or Hydroxychloroquine Sulfate
Gautret, Lagier, Parola, Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial, Int J Antimicrob Agents, doi:10.1016/j.ijantimicag.2020.105949
Ghazy, Almaghraby, Shaaban, A systematic review and meta-analysis on chloroquine and hydroxychloroquine as monotherapy or combined with azithromycin in COVID-19 treatment, Sci Rep, doi:10.1038/s41598-020-77748-x
Hamid, Abid, Amir, Current burden on healthcare systems in low-and middle-income countries: recommendations for emergency care of COVID-19, Drugs Ther Perspect, doi:10.1007/s40267-020-00766-2
Kaptein, Jacobs, Langendries, Favipiravir at high doses has potent antiviral activity in SARS-CoV-2-infected hamsters, whereas hydroxychloroquine lacks activity, Proc Natl Acad Sci U S A, doi:10.1073/pnas.2014441117
Kashour, Riaz, Garbati, E cacy of chloroquine or hydroxychloroquine in COVID-19 patients: a systematic review and meta-analysis, J Antimicrob Chemother, doi:10.1093/jac/dkaa403
Keyaerts, Vijgen, Maes, In vitro inhibition of severe acute respiratory syndrome coronavirus by chloroquine, Biochem Biophys Res Commun, doi:10.1016/j.bbrc.2004.08.085
Kirenga, Muttamba, Kayongo, Characteristics and outcomes of admitted patients infected with SARS-CoV-2 in Uganda, BMJ Open Respir Res, doi:10.1136/bmjresp-2020-000646
Liu, Cao, Xu, Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro, Cell Discov, doi:10.1038/s41421-020-0156-0
Ma, Chloroquine analogues in drug discovery: new directions of uses, mechanisms of actions and toxic manifestations from malaria to multifarious diseases, J Antimicrob Chemother, doi:10.1093/jac/dkv018
Mallat, Hamed, Balkis, Hydroxychloroquine is associated with slower viral clearance in clinical COVID-19 patients with mild to moderate disease, Medicine, doi:10.1097/MD.0000000000023720
Mitja, Corbacho-Monne, Ubals, A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19, N Engl J Med, doi:10.1056/NEJMoa2021801
Rajasingham, Bangdiwala, Nicol, Hydroxychloroquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial, medRxiv, doi:10.1101/2020.09.18.20197327
Srinivasa, Tosounidou, Gordon, Increased Incidence of Gastrointestinal Side Effects in Patients Taking Hydroxychloroquine: A Brand-related Issue?, J Rheumatol, doi:10.3899/jrheum.161063
Tang, Cao, Han, Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial, BMJ, doi:10.1136/bmj.m1849
Tonnesmann, Kandolf, Lewalter, Chloroquine cardiomyopathy -a review of the literature, Immunopharmacol Immunotoxicol, doi:10.3109/08923973.2013.780078
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While in vitro studies have demonstrated antiviral properties of ' 'HCQ, data from clinical trials were conflicting regarding its benefit for COVID-19 treatment. ' 'Drugs that limit viral replication may be beneficial in the earlier course of the disease ' 'thus slowing progression to severe and critical illness. <jats:bold>Design</jats:bold>We ' 'conducted a randomized open label Phase II clinical trial from October -December ' '2020.<jats:bold>Methods</jats:bold>Patients diagnosed with COVID-19 using RT-PCR were ' 'included in the study if they were 18 years and above and had a diagnosis of COVID-19 made in ' 'the last 3 days. Patients were randomized in blocks, to receive either HCQ 400mg twice a day ' 'for the first day followed by 200mg twice daily for the next 4 days plus standard of care ' '(SOC) treatment or SOC treatment alone. SARS COV-2 viral load using nasal/orapharyngeal swabs ' 'was performed at baseline, day 2, 4, 6, 8 and 10. 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Late treatment
is less effective
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