Off label use of Hydroxychloroquine and Azithromycin in COVID 19 (For attention of Doctors) |
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Off label use of Hydroxychloroquine and Azithromycin in COVID 19 (For attention of Doctors)

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Recommended treatment regimen: Hydroxychloroquine (200 mg three times per day and Azithromycin 500 mg once daily for 10 days

COVID-19 infection is linked with 155 mortality in patients above the age of 80 years, 85 in patients over 70 years and 3% in patients over 60 years. With no proven treatment yet available so far, medical researchers and doctors have been actively looking for off-label use of approved drugs in the management of COVID-19 cases.

In vitro studies have shown both chloroquine and hydroxychloroquine to inhibit SARS-CoV-2 with hydroxychloroquine exhibiting more potent antiviral action. [1]

China’s National Health Guidelines have recommended the use of chloroquine in the treatment of COVID-19. The drug has been reported to reduce disease progression as well as reduce duration of associated symptoms. [2, 3]. However, it must be noted here that primary data supporting these research findings are not yet available in the public domain. [4]

Another open-label study including 36 patients tested positive with COVID-19 showed that the use of 200 mg hydroxychloroquine administered 3 times a day for 10 days caused a higher rate of undetectable SARS-CoV-2 RNA in nasopharyngeal specimens at day 6 of the treatment as compared against patients receiving no specific treatment; with the percentage difference rising from12.5% (in non-treated patients) to 70% (in treated patients). [5]

With these preliminary findings at this stage, it is rational to use either one or both the agents in hospitalized patients with severe disease or those at risk for severe infection, especially if they are not eligible to participate in other clinical trials.

The Marseille study registered in the European Union Clinical Trials Register, included up to 25 COVID-19 patients, who were segregated based on age; 12-17 years (5 patients), 18-64 years(10 patients), 65 years or more (10 patients). In this unblended trial, the use of hydroxychloroquine reported a strong reduction in viral load with hydroxychloroquine. On the 6th day of the treatment, the number of patients testing positive for COVID-19 receiving hydroxychloroquine went down as compared to those who did not receive treatment (25% versus 90% respectively).

Additionally, when group of patients receiving different treatments was compared, it was also noted that patients receiving hydroxychloroquine and the antibiotic azithromycin showed a great reduction in the number of COVID-19 positive cases versus patients receiving hydroxychloroquine. On the 6th day of the treatment, the percentage of cases still carrying SARS-CoV-2 was restricted to 5% in those receiving hydroxychloroquine + antibiotic therapy. [6]

Current recommendations for the off-label treatment and prevention

  • In high risk patients including elderly; those with comorbid conditions; six-minutes’ walk distance<200 meters and healthcare professionals working on COVID like cases, the role of chloroquine (2 tablets per week or 2 tablets of hydroxychloroquine per week) is being considered among medical fraternity. ICMR should conduct also conduct an urgent review and deliberation on the same.
  • Recommended off-label use: Hydroxychloroquine-200 mg three times per day for 10 days + azithromycin 500 mg once daily for ten days in all COVID-19 suspected or confirmed cases
  • Recommended off-label use in all COVID-19 confirmed cases with respiratory decompensation i.e. exertional fall of SPO2 by 4% or clinical breathlessness
  • Hydroxychloroquine (200 mg three times per day for 10 days) plus azithromycin (500 mg once daily for 10 days) in all cases with high risk infection including persistent leukopenia, high SOFA score or D Dimer>1.
    • In such cases, Lopinavir (400 mg) plus Ritonavir (100 mg) twice daily or Lopinavir (800 mg) plus Ritonavir (200 mg) once daily may be added. [DCGI approved]


  1. Yao X, Ye F, Zhang M, et al. In 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 2020.
  2. Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends 2020; 14:72.
  3. Colson P, Rolain JM, Lagier JC, et al. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents 2020; :105932.
  4. Cortegiani A, Ingoglia G, Ippolito M, et al. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care 2020.
  5. Gautret et al. (2020) Hydroxychloroquine and azithromycin as a treatment of COVID‐19: results of an open‐label non‐randomized clinical trial. International Journal of Antimicrobial Agents – In Press 17 March 2020 DOI:10.1016/j.ijantimicag.2020.105949.
  6. The Marseille Study [International Journal of Antimicrobial Agents].

Difference between Quarantine, Isolation an Scial Distancing 

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA

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