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All Studies   Meta Analysis    Recent:   

Chlorpheniramine Intranasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient Setting: The ACCROS Trials

Valerio-Pascua et al., Research Square, doi:10.21203/rs.3.rs-2167465/v1, ACCROS-II, NCT05520944
Oct 2022  
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Recovery time 54% Improvement Relative Risk Chlorpheniramine  ACCROS-II  EARLY TREATMENT Is early treatment with chlorpheniramine beneficial for COVID-19? Retrospective 660 patients in multiple countries (Jun 2021 - Jul 2022) Faster recovery with chlorpheniramine (p<0.000001) c19early.org Valerio-Pascua et al., Research Square, Oct 2022 Favorschlorpheniramine Favorscontrol 0 0.5 1 1.5 2+
10th treatment shown to reduce risk in December 2020
 
*, now with p = 0.00006 from 15 studies.
Lower risk for mortality, recovery, and cases.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 81 treatments. c19early.org
RCT and retrospective study of chlorpheniramine nasal spray for COVID-19. The retrospective study included 660 outpatients showing fewer days with general COVID-19 symptoms, cough, anosmia, and ageusia compared to standard of care alone. The RCT results are listed separately1.
3 studies use direct respiratory tract administration1-3
Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects.
Study covers antihistamine H1RAs and chlorpheniramine.
recovery time, 54.3% lower, relative time 0.46, p < 0.001, treatment mean 4.97 (±3.32) n=330, control mean 10.88 (±6.64) n=330.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Valerio-Pascua et al., 18 Oct 2022, retrospective, multiple countries, preprint, 16 authors, study period June 2021 - July 2022, trial NCT05520944 (history) (ACCROS-II). Contact: rahaghf@ccf.org.
This PaperH1RAsAll
{ 'institution': [{'name': 'Research Square'}], 'indexed': { 'date-parts': [[2022, 10, 25]], 'date-time': '2022-10-25T05:06:49Z', 'timestamp': 1666674409162}, 'posted': {'date-parts': [[2022, 10, 18]]}, 'group-title': 'In Review', 'reference-count': 39, 'publisher': 'Research Square Platform LLC', 'license': [ { 'start': { 'date-parts': [[2022, 10, 18]], 'date-time': '2022-10-18T00:00:00Z', 'timestamp': 1666051200000}, 'content-version': 'unspecified', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0/'}], 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'accepted': {'date-parts': [[2022, 10, 14]]}, 'abstract': '<jats:title>Abstract</jats:title>\n' ' <jats:p><jats:bold>Purpose: </jats:bold>Our group demonstrated the safety, efficacy, ' 'and antiviral effect of intranasally administered Chlorpheniramine Maleate (CPM) for treating ' 'coronavirus disease 2019 (COVID-19). Since the nasal cavity is the portal of entry for COVID ' 'pathogens, sensory and upper respiratory symptoms (URS) (e.g., cough, ageusia, anosmia, nasal ' 'congestion, etc.) are significant symptoms in the course of the disease. Intranasal therapies ' 'could alleviate the disease-induced URS faster. This study evaluated the effectiveness and ' 'safety of intranasal CPM for treating mild to moderate COVID-19-induced URS in the outpatient ' 'setting.\n' '<jats:bold>Methods: </jats:bold>The two-part <jats:bold>A</jats:bold>ccelerating ' '<jats:bold>C</jats:bold>OVID-19 <jats:bold>C</jats:bold>linical ' '<jats:bold>R</jats:bold>ecovery in an <jats:bold>O</jats:bold>utpatient ' '<jats:bold>S</jats:bold>etting (ACCROS) research study was conducted to collect evidence from ' 'a randomized, double-blinded placebo-controlled trial (ACCROS-I). Both parts enrolled ' 'patients with mild to moderate COVID-19 confirmed by reverse transcription-polymerase chain ' 'reaction. The primary endpoint in ACCROS-I was time to clinical recovery, defined as the ' 'change from baseline to day 7 in COVID-19 symptoms reported as the percent change (Δ%) in the ' 'daily symptoms score (DSS) and the severity of the disease symptoms using a visual analog ' 'scale (VAS), on a scale of 1-10 (10=worst symptoms). COVID-19 patients (n = 101) were ' 'recruited and assigned to either a 10-day CPM treatment (n=61) or placebo (PLB) (n=40) in ' 'addition to standard of care (SoC). Secondary endpoints included the incidence of ' 'hospitalization and the proportion of patients with URS on day 7. ACCROS-II data were ' 'collected from medical records of COVID-positive subjects using a standardized form. Cohorts ' 'of patients treated with CPM and SoC (CPM+Soc) were compared for the duration of general ' 'symptoms and URS. Patient information was collected as part of routine visits and telehealth ' 'consultations.\n' '<jats:bold>Results </jats:bold><jats:italic>ACCROS-I:</jats:italic> There was a statistically ' 'significant difference in the rate of clinical recovery (P&lt;0.05) in Δ%DSS (M -18.8±SEM ' '7.9%) and Δ%VAS (-8.6±5.1%), such that the CPM group reported fewer symptoms than PLB. The ' 'proportion of patients who reported sensory deficits and URS at day 7 was significantly lower ' '(P&lt;0.05) in CPM vs. PLB for ageusia (1.7% vs. 15.0%), cough (16.4% vs. 35.0%) and nasal ' 'congestion (8.1%vs.20%). None of the patients required hospitalization.\n' '<jats:italic>ACCROS-II</jats:italic>: There was a statistically significant reduction ' '(P&lt;0.05) in total days reporting URS for general symptoms of COVID-19 in CPM+SoC (5.1 ± ' '0.1) compared to SoC (11.0 ± 0.2). CPM+SoC users also showed fewer days with cough, anosmia, ' 'and ageusia. Persistent anosmia (over 29 days) was found in 3% of the patients on SoC, ' 'whereas no persistent anosmia was reported in the CPM+SoC cohort (X<jats:sup>2</jats:sup> = ' '10.18; P&lt;0.001).\n' '<jats:bold>Conclusion:</jats:bold> The result of this two-part study supports the conclusion ' 'that intranasal CPM is an antiviral agent that can be administered intranasally to treat ' 'COVID-19-induced symptoms effectively. Intranasal CPM accelerates clinical recovery and ' "reduces URS in patients with mild to moderate COVID-19. This study's important implications " 'include individuals returning to daily life faster, reducing community and individual ' 'economic burden, and decreasing healthcare utilization.\n' '<jats:bold>Trial registration:</jats:bold> ClinicalTrials.gov.; ID: NCT05449405 ACCROS-I ' 'retrospectively registered on 7/13/2022, NCT05520944 ACCROS-R retrospectively registered on ' '08/27/2022.</jats:p>', 'DOI': '10.21203/rs.3.rs-2167465/v1', 'type': 'posted-content', 'created': { 'date-parts': [[2022, 10, 18]], 'date-time': '2022-10-18T18:11:18Z', 'timestamp': 1666116678000}, 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Chlorpheniramine Intranasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient ' 'Setting: The ACCROS Trials', 'prefix': '10.21203', 'author': [ { 'given': 'Fernando', 'family': 'Valerio-Pascua', 'sequence': 'first', 'affiliation': [{'name': 'Hospital CEMESA Cortés'}]}, { 'given': 'Estela Jackeline Pineda', 'family': 'Mejia', 'sequence': 'additional', 'affiliation': [{'name': 'Hospital CEMESA Cortés'}]}, { 'given': 'Mari L.', 'family': 'Tesch', 'sequence': 'additional', 'affiliation': [{'name': 'Aventura Hospital Pulmonary and Critical Care Fellowship'}]}, { 'given': 'Jancy', 'family': 'Godoy', 'sequence': 'additional', 'affiliation': [{'name': 'Hospital Leonardo Martínez Valenzuela'}]}, { 'given': 'Carlos López', 'family': 'Fuentes', 'sequence': 'additional', 'affiliation': [{'name': 'Universidad Católica de Honduras'}]}, { 'given': 'Gloria B.', 'family': 'Erazo', 'sequence': 'additional', 'affiliation': [{'name': 'Universidad Católica de Honduras'}]}, { 'given': 'Marco', 'family': 'Bermúdez', 'sequence': 'additional', 'affiliation': [{'name': 'Universidad Católica de Honduras'}]}, { 'given': 'Miguel Fernando Vargas', 'family': 'Pineda', 'sequence': 'additional', 'affiliation': [{'name': 'Saint Barnabas Hospital'}]}, { 'given': 'Syed A.A.', 'family': 'Rivzi', 'sequence': 'additional', 'affiliation': [{'name': 'Hampton University School of Pharmacy'}]}, { 'given': 'Armando', 'family': 'Cabrera', 'sequence': 'additional', 'affiliation': [{'name': 'Aventura Hospital Pulmonary and Critical Care Fellowship'}]}, { 'given': 'Zeeshan', 'family': 'Chauhan', 'sequence': 'additional', 'affiliation': [{'name': 'Aventura Hospital Pulmonary and Critical Care Fellowship'}]}, { 'given': 'Scarlet', 'family': 'Grullón-Franco', 'sequence': 'additional', 'affiliation': [{'name': 'Clinica Universitaria Union Medica'}]}, { 'given': 'Jorge L.', 'family': 'Paulino-Then', 'sequence': 'additional', 'affiliation': [{'name': 'Clinica Universitaria Union Medica'}]}, { 'given': 'Natalia', 'family': 'Garcia', 'sequence': 'additional', 'affiliation': [{'name': 'Clinica Universitaria Union Medica'}]}, { 'given': 'Jeffrey D.', 'family': 'Williams', 'sequence': 'additional', 'affiliation': [{'name': 'The George Washington University'}]}, { 'given': 'Franck F.', 'family': 'Rahaghi', 'sequence': 'additional', 'affiliation': [{'name': 'Cleveland Clinic'}]}], 'member': '8761', 'reference': [ { 'issue': '6', 'key': 'ref1', 'doi-asserted-by': 'crossref', 'first-page': 'ofac138', 'DOI': '10.1093/ofid/ofac138', 'article-title': 'A Systematic Review of Coronavirus Disease 2019 Vaccine Efficacy and ' 'Effectiveness Against Severe Acute Respiratory Syndrome Coronavirus 2 ' 'Infection and Disease', 'volume': '9', 'author': 'Higdon MM', 'year': '2022', 'unstructured': 'Higdon, M.M., et al., A Systematic Review of Coronavirus Disease 2019 ' 'Vaccine Efficacy and Effectiveness Against Severe Acute Respiratory ' 'Syndrome Coronavirus 2 Infection and Disease. 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