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Sumanth Khadke, MD[1]

Rana Aljebzi, MD[2]

Nuha Al-Howthi, MD[3]


Eman Alademi, MD[4]




Medication

Hydroxychloroquine

215 studies worldwide 55 studies in the USA Placebo: Vitamin D, Pacebo: Calcium citrate, Vit C, Mannitol, glucose tablets, Folic Acid, Ascorbic Acid Combination/comparison: Drug: Vitamin D, Zinc sulfate, Azythromycin, Doxycycline,Indomethacin, Zithromax Oral Product, Ivermectin, Camostat Mesilate, Bromhexine, Nitazoxanide, Lopinavir/ritonavir, Sirolimus, Telmisartan, Active Comparator (Ciclesonide inhalor), Favipiravir, diltiazem and niclosamide, Clevudine, Lopinavir/ritonavir, Favipiravir, Interferon-β 1a, Bromhexine, Baricitinib, Nitazoxanide,



Purpose of study:

Primary prevention Post-exposure prophylaxis Treatment Clinical improvement Viral load clearance from Nasopharyngeal sample

Design/Strategy:

Phase 2 vs 3 vs 4 2 arm study vs 4 arm study Dose-based (200 vs 400 vs 600 mg) Frequenc-based ( Once vs twice vs trice per day) Duration-based (5 vs 10 vs 14 ... days)

Hydroxychloroquine

Country Intervention Objective Design&Date Strategy Outcome
Renmin Hospital of Wuhan University, China[1] Hydroxychloroquine (HCQ)

(Preprint article)

Treatment efficacy evaluation
  • February 4 to February 28, 2020
  • 62 patients with confirmed COVID-19 diagnosis
  • Participants were randomized in a parallel-group trial
  • Males: 46.8%; Female: 53.2%; Mean age: 44.7 years. age and sex were adjusted between the control group and the HCQ group
  • 31 patients treatment group
  • A 5-day HCQ (400 mg/d) treatment
  • The HCQ effect was evaluated at baseline and 5 days after treatment by assessing the following:
    • Time to clinical recovery (TTCR), clinical characteristics, and radiological results
  • TTCR, the body temperature recovery time and the cough remission time were significantly shortened in the HCQ treatment group
  • (80.6%, 25 of 31of patients with improved pneumonia in the HCQ treatment group compared with the control group (54.8%, 17 of 31)
  • 4 patients progressed to severe illness that occurred in the control group
  • 2 patients with mild adverse reactions in the HCQ treatment group
  • Conclusion: The use of HCQ could significantly shorten TTCR and promote the absorption of pneumonia in patients with COVID-19
Méditerranée Infection University Hospital Institute in Marseille, France[2] Hydroxychloroquine and azithromycin Treatment efficacy evaluation
  • Early March to March 16th
  • 36 out of 42 patients meeting the inclusion criteria
  • 6 lost to follow up
  • 20 hydroxychloroquine-treated patients
  • 16 control patients
  • Patients were included in a single-arm protocol
  • Inclusion criteria:
    • Age >12 years
    • PCR documented SARS-CoV-2 carriage in nasopharyngeal sample at admission regardless of the clinical status
  • Control was untreated patients from another center and cases refusing the protocol
  • Endpoint: presence and absence of virus at Day6-post inclusion
  • 600mg of HCQ daily
    • 200 mg, three times per day for ten days
  • Viral load in nasopharyngeal swabs was tested daily in a hospital setting

Azithromycin:

  • Added depending on the clinical presentation
  • 500mg on day1 followed by 250mg per day, the next four days
  • To prevent bacterial super-infection under daily electrocardiogram control
  • There was a statistically significant difference between treated patients and controls at days 3-4-5 and 6 (negative PCR)
  • At day 6, 70% of HCQ-treated patients were virologically cured comparing with 12.5% in the control group (p= 0.001)

HCQ vs HCQ-Azithromycin combination

  • There was a statistically significant difference between treated patients and controls at days 3-4-5 and 6 (negative PCR)
  • At day 6, 100% of patients treated with HCQ and azithromycin combination were virologically cured comparing with 57.1% in patients treated with HCQ only, and 12.5% in the control group (p < 0.001)

Conclusion:

  • HCQ is significantly associated with viral load reduction/disappearance in COVID-19 patients and its effect is reinforced by azithromycin
Marqués de Valdecilla University Hospital, Cantabria, Spain[3] HDQ Chemoprophylaxis
  • Start scheduled for the second week of May 2020
  • Prospective, single center, double blind, randomised, controlled trial (RCT)
  • 450 Adult health-care professionals (18-65 years)
  • Working in areas of high exposure and high risk of transmission of SARS-COV-2
  • Oral Hydroxychloroquine 200mg, once-daily, for two months (HC group) or placebo (P group)
    1. Intervention: (n = 225): One 200 mg hydroxychloroquine sulfate coated tablet once daily for two months.
    2. Comparator (control group) (n = 225): One hydroxychloroquine placebo tablet (identical to that of the drug) once daily for two months
  • In addition to the protective measures appropriate to the level of exposure established by the hospital.
  • A serological evaluation every 15 days with PCR in case of seroconversion, symptoms or risk exposure.
Eight hospitals in Spain[4] Melatonin Prophylaxis Recruitement (May 21-31)

450 participants

225 in the experimental arm

225 in the placebo arm.

Experimental: Melatonin (Circadin®, 2 mg of melatonin orally before bedtime for 12 weeks.

Comparator: Identical looking placebo, orally before bedtime for 12 weeks.

  1. Chen, Zhaowei; Hu, Jijia; Zhang, Zongwei; Jiang, Shan; Han, Shoumeng; Yan, Dandan; Zhuang, Ruhong; Hu, Ben; Zhang, Zhan (2020). doi:10.1101/2020.03.22.20040758. Missing or empty |title= (help)
  2. Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M; et al. (2020). "Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial". Int J Antimicrob Agents: 105949. doi:10.1016/j.ijantimicag.2020.105949. PMC 7102549 Check |pmc= value (help). PMID 32205204 Check |pmid= value (help).
  3. Cuadrado-Lavín A, Olmos JM, Cifrian JM, Gimenez T, Gandarillas MA, García-Saiz M; et al. (2020). "Controlled, double-blind, randomized trial to assess the efficacy and safety of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in healthcare personnel in the hospital setting: A structured summary of a study protocol for a randomised controlled trial". Trials. 21 (1): 472. doi:10.1186/s13063-020-04400-4. PMC 7268173 Check |pmc= value (help). PMID 32493494 Check |pmid= value (help).
  4. García IG, Rodriguez-Rubio M, Mariblanca AR, de Soto LM, García LD, Villatoro JM; et al. (2020). "A randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts (MeCOVID Trial): A structured summary of a study protocol for a randomised controlled trial". Trials. 21 (1): 466. doi:10.1186/s13063-020-04436-6. PMC 7267766 Check |pmc= value (help). PMID 32493475 Check |pmid= value (help).