Chloroquine nasal drops in asymptomatic & mild COVID-19: An exploratory randomized clinical trial
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...
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| Veröffentlicht in: | Indian journal of medical research (New Delhi, India : 1994) India : 1994), 2021-01, Vol.153 (1), p.151-158 |
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| creator | Thakar, Alok Panda, Smriti Sakthivel, Pirabu Brijwal, Megha Dhakad, Shivram Choudekar, Avinash Kanodia, Anupam Bhatnagar, Sushma Mohan, Anant Maulik, Subir Dar, Lalit |
| description | 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 transcription-polymerase 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 |
| doi_str_mv | 10.4103/ijmr.IJMR_3665_20 |
| format | Article |
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Methods: This randomized clinical trial was done with a sample size of 60. Reverse transcription-polymerase 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.</description><identifier>ISSN: 0971-5916</identifier><identifier>DOI: 10.4103/ijmr.IJMR_3665_20</identifier><identifier>PMID: 33473017</identifier><language>eng</language><publisher>India: Wolters Kluwer India Pvt. Ltd</publisher><subject>Asymptomatic ; Chloroquine ; Clinical trials ; Coronaviruses ; COVID-19 ; Dosage and administration ; Infections ; Intranasal medication ; Patient outcomes ; Vital signs</subject><ispartof>Indian journal of medical research (New Delhi, India : 1994), 2021-01, Vol.153 (1), p.151-158</ispartof><rights>COPYRIGHT 2021 Medknow Publications and Media Pvt. Ltd.</rights><rights>2021. This article is published under (http://creativecommons.org/licenses/by-nc-sa/3.0/) (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c462u-e2d29894a281e1c25d28bf60fe8c0b45f20b566802f9fc218556bf0911ba29603</citedby><cites>FETCH-LOGICAL-c462u-e2d29894a281e1c25d28bf60fe8c0b45f20b566802f9fc218556bf0911ba29603</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33473017$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Thakar, Alok</creatorcontrib><creatorcontrib>Panda, Smriti</creatorcontrib><creatorcontrib>Sakthivel, Pirabu</creatorcontrib><creatorcontrib>Brijwal, Megha</creatorcontrib><creatorcontrib>Dhakad, Shivram</creatorcontrib><creatorcontrib>Choudekar, Avinash</creatorcontrib><creatorcontrib>Kanodia, Anupam</creatorcontrib><creatorcontrib>Bhatnagar, Sushma</creatorcontrib><creatorcontrib>Mohan, Anant</creatorcontrib><creatorcontrib>Maulik, Subir</creatorcontrib><creatorcontrib>Dar, Lalit</creatorcontrib><title>Chloroquine nasal drops in asymptomatic & mild COVID-19: An exploratory randomized clinical trial</title><title>Indian journal of medical research (New Delhi, India : 1994)</title><addtitle>Indian J Med Res</addtitle><description>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 transcription-polymerase 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.</description><subject>Asymptomatic</subject><subject>Chloroquine</subject><subject>Clinical trials</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>Dosage and administration</subject><subject>Infections</subject><subject>Intranasal medication</subject><subject>Patient outcomes</subject><subject>Vital signs</subject><issn>0971-5916</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp1kltrFDEYhudCsbX6A7yRgCDezJrDJDPxbhmtrlQKot6GTCbRbHOYJjOs219vlm09oeQiEJ734ft4U1VPEFw1CJKXduvTavP-w0dBGKMCw3vVKeQtqilH7KR6mPMWQsRxyx9UJ4Q0LYGoPa1k_83FFK8XGzQIMksHxhSnDGwAMu_9NEcvZ6vAc-CtG0F_-WXzukb8FVgHoL9PJSznmPYgyTBGb2_0CJSzwapimpOV7lF130iX9ePb-6z6fP7mU_-uvrh8u-nXF7VqGF5qjUfMO95I3CGNFKYj7gbDoNGdgkNDDYYDZayD2HCjMOooZYOBHKFBYs4gOateHL3TYR2dZ-FtVto5GXRcssAUdsWPISros7_QbVxSKNMVimAGKSL4F_VVOi1sMHFOUh2kYs0o4y3HnBdq9Q-qnFF7q2LQxpb3PwLoGFAp5py0EVOyXqa9QFAcqhSHKsXvVZbM09uBl8Hr8WfirscC9EdgF92sU75yy04nUdirEHf_NwtEkbj7AuQH0jux4Q</recordid><startdate>20210101</startdate><enddate>20210101</enddate><creator>Thakar, Alok</creator><creator>Panda, Smriti</creator><creator>Sakthivel, Pirabu</creator><creator>Brijwal, Megha</creator><creator>Dhakad, Shivram</creator><creator>Choudekar, Avinash</creator><creator>Kanodia, Anupam</creator><creator>Bhatnagar, Sushma</creator><creator>Mohan, Anant</creator><creator>Maulik, Subir</creator><creator>Dar, Lalit</creator><general>Wolters Kluwer India Pvt. 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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 transcription-polymerase 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.</abstract><cop>India</cop><pub>Wolters Kluwer India Pvt. Ltd</pub><pmid>33473017</pmid><doi>10.4103/ijmr.IJMR_3665_20</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Indian journal of medical research (New Delhi, India : 1994), 2021-01, Vol.153 (1), p.151-158 |
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| source | PubMed Central Open Access; PubMed Central |
| subjects | Asymptomatic Chloroquine Clinical trials Coronaviruses COVID-19 Dosage and administration Infections Intranasal medication Patient outcomes Vital signs |
| title | Chloroquine nasal drops in asymptomatic & mild COVID-19: An exploratory randomized clinical trial |
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