Chloroquine nasal drops in asymptomatic & mild COVID-19: An exploratory randomized clinical trial
Thakar et al.,
Chloroquine nasal drops in asymptomatic & mild COVID-19: An exploratory randomized clinical trial,
Indian J. Med. Res., doi:10.4103/ijmr.IJMR_3665_20
Small RCT for CQ nasal drops suggesting efficacy in preventing infection, while no significant difference was seen for patients that already had mild COVID-19.
Thakar et al., 28 Feb 2021, peer-reviewed, 11 authors.
Abstract: Indian J Med Res 153, January & February 2021, pp 151-158
DOI: 10.4103/ijmr.IJMR_3665_20
Quick Response Code:
Chloroquine nasal drops in asymptomatic & mild COVID-19: An
exploratory randomized clinical trial
Alok Thakar1, Smriti Panda1, Pirabu Sakthivel1, Megha Brijwal2, Shivram Dhakad2, Avinash Choudekar2,
Anupam Kanodia1, Sushma Bhatnagar3, Anant Mohan4, Subir K. Maulik5 & Lalit Dar2
Departments of 1Otorhinolaryngology & Head & Neck Surgery, 2Microbiology, 3Oncoanesthesia, 4Pulmonary
Medicine & Sleep Disorders & 5Pharmacology, All India Institute of Medical Sciences, New Delhi, India
Received August 28, 2020
Background & objectives: Chloroquine (CQN) administered as nasal drops has the potential to achieve
much greater local tissue levels than with oral/systemic administration. This trial was undertaken to
study the efficacy and safety profile of topical nasal administration of CQN drops in reducing viral load
and preventing clinical progression in early COVID-19 infection.
Methods: This randomized clinical trial was done with a sample size of 60. Reverse transcriptionpolymerase chain reaction (RT-PCR) confirmed asymptomatic patients or those with mild COVID-19
illness [National Early Warning Score (NEWS) ≤4] were included. Patients were randomized in a 1:1
manner. Control arm (standard supportive treatment, n=30) was compared with intervention arm
(n=30) of standard treatment plus CQN eye drops (0.03%) repurposed as nasal drops administered six
times daily (0.5 ml/dose) for 10 days. Outcome measures were adverse events and adherence; clinical
progression and outcomes were measured by NEWS; sequential RT-PCR cycle threshold (Ct) values
were also noted on days 0, 3, 7 and 10.
Results: Nasal CQN was associated with local irritation in seven and non-compliance in one of 30 patients.
Eleven patients were excluded due to enrolment error (2 – recovered; 9 – false-positive referral), and 49
patients were analyzed as per modified intention-to-treat analysis. Clinical recovery was noted as similar
with 100 per cent asymptomatic by day seven in both arms. Virological outcomes also indicated similarly
improving Ct values in both arms, and similar proportion of patients transitioning to non-infectivity by
day 10 (controls - 19/25; nasal CQN - 15/24). Nine false-positive patients with enrolment error and day
0 RT-PCR negative were initially uninfected but had continuing COVID-19 exposure and treatment as
per randomization. Patients receiving nasal CQN (n=5) demonstrated stable Ct values from day 0 to 10,
while patients with no nasal CQN (n=4) demonstrated significant dip in Ct value indicating to infection
(Ct<35) and infectivity (Ct<33).
Interpretation & conclusions: The present study suggests to the potential of topical nasal CQN in the
prevention of COVID-19 infection if administered before the infection is established. No significant
differences in clinical or virological outcome were however, demonstrated in patients with mild but
established illness.
Key words Chloroquine - COVID-19 - nasal drops - National Early Warning Score - prophylaxis - SARS CoV-2
© 2021 Indian Journal of Medical Research, published by Wolters Kluwer - Medknow for Director-General, Indian Council of Medical Research
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INDIAN J MED RES, JANUARY & FEBRUARY 2021
Chloroquine (CQN) and hydroxychloroquine
(HCQ) have been demonstrated to have antiviral activity
against the coronaviruses and novel coronavirus 2
(SARS-CoV-2) in cell culture and in animal..
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