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All Studies   Meta Analysis    Recent:   

Efficacy and Safety of Andrographolide and Favipiravir Versus Favipiravir Monotherapy in Patients with Mild COVID-19 Infection: A Multicenter Randomized Controlled Trial

Prasoppokakorn et al., OBM Integrative and Complementary Medicine, doi:10.21926/obm.icm.2401013, TCTR20210906002
Feb 2024  
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Recovery, all symptoms.. 37% Improvement Relative Risk Recovery, day 7, fever 18% Recovery, day 7, cough 46% Recovery, day 7, myalgia 55% Recovery, day 7, headache 40% Recovery, day 7, sore throat 30% Recovery, day 7, rhinitis 42% Recovery, all symp.. (b) 45% Recovery, day 14, fever 55% Recovery, day 14, cough 48% Recovery, day 14, headache 68% Recovery, day 14, sore thr.. 9% Recovery, day 14, rhinitis 9% Andrographolide  Prasoppokakorn et al.  EARLY TREATMENT  RCT Is early treatment with andrographolide beneficial for COVID-19? RCT 82 patients in Thailand (October 2021 - February 2022) Improved recovery with andrographolide (p=0.005) c19early.org Prasoppokakorn et al., OBM Integrative.., Feb 2024 Favorsandrographolide Favorscontrol 0 0.5 1 1.5 2+
Randomized controlled trial of 82 mild COVID-19 outpatients showing significantly greater reduction in cough and lower inflammatory markers at day 7. Symptomatic improvement was significant at day 7 when combining all symptoms reported, but not for other symptoms individually. There was no progression to severe pneumonia in either group.
risk of no recovery, 37.5% lower, RR 0.63, p = 0.005, treatment 43, control 39, all symptoms combined.
risk of no recovery, 17.5% lower, RR 0.82, p = 0.62, treatment 10 of 43 (23.3%), control 11 of 39 (28.2%), NNT 20, day 7, fever.
risk of no recovery, 46.4% lower, RR 0.54, p = 0.03, treatment 13 of 43 (30.2%), control 22 of 39 (56.4%), NNT 3.8, day 7, cough.
risk of no recovery, 54.7% lower, RR 0.45, p = 0.60, treatment 1 of 43 (2.3%), control 2 of 39 (5.1%), NNT 36, day 7, myalgia.
risk of no recovery, 39.5% lower, RR 0.60, p = 0.66, treatment 2 of 43 (4.7%), control 3 of 39 (7.7%), NNT 33, day 7, headache.
risk of no recovery, 30.2% lower, RR 0.70, p = 0.34, treatment 10 of 43 (23.3%), control 13 of 39 (33.3%), NNT 9.9, day 7, sore throat.
risk of no recovery, 42.3% lower, RR 0.58, p = 0.29, treatment 7 of 43 (16.3%), control 11 of 39 (28.2%), NNT 8.4, day 7, rhinitis.
risk of no recovery, 45.0% lower, RR 0.55, p = 0.18, treatment 43, control 39, all symptoms combined.
risk of no recovery, 54.7% lower, RR 0.45, p = 0.60, treatment 1 of 43 (2.3%), control 2 of 39 (5.1%), NNT 36, day 14, fever.
risk of no recovery, 48.2% lower, RR 0.52, p = 0.34, treatment 4 of 43 (9.3%), control 7 of 39 (17.9%), NNT 12, day 14, cough.
risk of no recovery, 67.8% lower, RR 0.32, p = 0.48, treatment 0 of 43 (0.0%), control 1 of 39 (2.6%), NNT 39, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 14, headache.
risk of no recovery, 9.3% lower, RR 0.91, p = 1.00, treatment 1 of 43 (2.3%), control 1 of 39 (2.6%), NNT 419, day 14, sore throat.
risk of no recovery, 9.3% lower, RR 0.91, p = 1.00, treatment 1 of 43 (2.3%), control 1 of 39 (2.6%), NNT 419, day 14, rhinitis.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Prasoppokakorn et al., 2 Feb 2024, Randomized Controlled Trial, Thailand, peer-reviewed, 7 authors, study period October 2021 - February 2022, trial TCTR20210906002. Contact: thanineeeve@gmail.com, supachaya.sr@gmail.com, ercp@live.com, nutbordee@gmail.com, thitagiftr@gmail.com, pongtornmd18@gmail.com, pisittkvn@yahoo.com.
This PaperAndrographol..All
Efficacy and Safety of Andrographolide and Favipiravir Versus Favipiravir Monotherapy in Patients with Mild COVID-19 Infection: A Multicenter Randomized Controlled Trial
Thaninee Prasoppokakorn, Supachaya Sriphoosanaphan, Nutbordee Nalinthassanai, Thitaporn Roongrawee, Pongtorn Hanboonkunupakarn, Pisit Tangkijvanich, Rungsun Rerknimitr
OBM Integrative and Complementary Medicine, doi:10.21926/obm.icm.2401013
Reports indicate that Andrographolide inhibits viral replication and reduces COVID-19 symptoms. This study aimed to determine Andrographolide's additional effect and safety in mild COVID-19 patients treated with favipiravir. A multicenter, open-labeled, randomized controlled trial was conducted from October 2021 to February 2022. The patients were randomized to receive a combination of Andrographolide and favipiravir or favipiravir monotherapy. The primary outcome was the occurrence rate of severe pneumonia. The secondary outcomes were symptom improvement, inflammatory biomarkers, and adverse events on days 7 and 14. 82 mild COVID-19 patients were enrolled; 43 and 39 patients received either combination therapy or favipiravir alone. Baseline characteristics were comparable. None developed severe pneumonia, requiring a mechanical ventilator. The Andrographolide group had a significant reduction of cough compared to the controlled group; 13 (30.2%) vs. 22 (56.4%), p = 0.017 on day 7 and 4 (9.3%) vs. 7 (17.9%), p = 0.025 on day 14. Moreover, the Andrographolide group had significantly lower levels of inflammatory markers on day 7, CRP (5.8 vs. 18.4 mg/L; p = 0.019) and IL-6 (2.0 vs. 21.8 pg/mL; p = 0.001) but not on day 14. Regarding safety outcomes, the Andrographolide group had significantly higher AST levels on day 7 (40.3 vs. 32.2 U/L; p = 0.030) and both AST and ALT levels on day 14 (55.3 vs. 32.0; p = 0.014 and 63.8 vs. 40.0; p = 0.022, respectively). In mild COVID-19 patients, the combination of Andrographolide and favipiravir did not demonstrate additional benefits over favipiravir alone in preventing severe pneumonia. However, Andrographolide significantly reduced cough symptoms, especially during the first week. Furthermore, despite mild transaminitis, patients treated with Andrographolide showed improvements in inflammatory markers.
Author Contributions Thaninee Prasoppokakorn, Supachaya Sriphoosanaphan, Rungsun Rerknimitr -Conceptual design of the work; Nutbordee Nalinthassanai, Thitaporn Roongrawee, Pongtorn Hanboonkunupakarn, Pisit Tangkijvanich -Data collection and data acquisition; Thaninee Prasoppokakorn, Supachaya Sriphoosanaphan, Rungsun Rerknimitr -Data analysis and interpretation; Thaninee Prasoppokakorn -Drafting the manuscript; Supachaya Sriphoosanaphan, Rungsun Rerknimitr -Critical revision of the manuscript; All authors -Final approval of the version to be published. Competing Interests The authors declare no conflicts of interests.
References
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Ferreira, Polonini, Dijkers, Postulated adjuvant therapeutic strategies for COVID-19, J Pers Med
Guérin, Mclean, Rashan, Lawal, Watson et al., Definitions matter: Heterogeneity of COVID-19 disease severity criteria and incomplete reporting compromise meta-analysis, PLoS Glob Public Health
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Sirijatuphat, Manosuthi, Niyomnaitham, Owen, Copeland et al., Early treatment of favipiravir in COVID-19 patients without pneumonia: A multicentre, openlabelled, randomized control study, Emerg Microbes Infect
Siripongboonsitti, Ungtrakul, Tawinprai, Auewarakul, Chartisathian et al., Efficacy of Andrographis paniculata extract treatment in mild to moderate COVID-19 patients being treated with favipiravir: A double-blind, randomized, placebo-controlled study (APFaVi trial), Phytomedicine
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Statsenko, Zahmi, Habuza, Almansoori, Smetanina et al., Impact of age and sex on COVID-19 severity assessed from radiologic and clinical findings, Front Cell Infect Microbiol
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Zhu, Hou, Yang, Network pharmacology integrated with experimental validation revealed the anti-inflammatory effects of Andrographis paniculata, Sci Rep
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The secondary ' 'outcomes were symptom improvement, inflammatory biomarkers, and adverse events on days 7 and ' '14. 82 mild COVID-19 patients were enrolled; 43 and 39 patients received either combination ' 'therapy or favipiravir alone. Baseline characteristics were comparable. None developed severe ' 'pneumonia, requiring a mechanical ventilator. The Andrographolide group had a significant ' 'reduction of cough compared to the controlled group; 13 (30.2%) vs. 22 (56.4%), p = 0.017 on ' 'day 7 and 4 (9.3%) vs. 7 (17.9%), p = 0.025 on day 14. Moreover, the Andrographolide group ' 'had significantly lower levels of inflammatory markers on day 7, CRP (5.8 vs. 18.4 mg/L; p = ' '0.019) and IL-6 (2.0 vs. 21.8 pg/mL; p = 0.001) but not on day 14. Regarding safety outcomes, ' 'the Andrographolide group had significantly higher AST levels on day 7 (40.3 vs. 32.2 U/L; p ' '= 0.030) and both AST and ALT levels on day 14 (55.3 vs. 32.0; p = 0.014 and 63.8 vs. 40.0; p ' '= 0.022, respectively). 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The efficacy and safety of favipiravir in treatment ' 'of COVID-19: A systematic review and meta-analysis of clinical trials. ' 'Sci Rep. 2021; 11: 11022.', 'DOI': '10.1038/s41598-021-90551-6'}, { 'key': 'ref=2', 'doi-asserted-by': 'crossref', 'unstructured': 'Sirijatuphat R, Manosuthi W, Niyomnaitham S, Owen A, Copeland KK, ' 'Charoenpong L, et al. Early treatment of favipiravir in COVID-19 ' 'patients without pneumonia: A multicentre, open-labelled, randomized ' 'control study. Emerg Microbes Infect. 2022; 11: 2197-2206.', 'DOI': '10.1080/22221751.2022.2117092'}, { 'key': 'ref=3', 'doi-asserted-by': 'crossref', 'unstructured': 'Joshi S, Parkar J, Ansari A, Vora A, Talwar D, Tiwaskar M, et al. Role ' 'of favipiravir in the treatment of COVID-19. Int J Infect Dis. 2021; ' '102: 501-508.', 'DOI': '10.1016/j.ijid.2020.10.069'}, { 'key': 'ref=4', 'doi-asserted-by': 'crossref', 'unstructured': 'Vieillard-Baron A, Flicoteaux R, Salmona M, Annane D, Ayed S, Azoulay E, ' 'et al. Epidemiological characteristics and severity of omicron variant ' 'cases in the APHP critical care units. MedRxiv. 2022. doi: ' '10.1101/2022.01.25.22269839.', 'DOI': '10.1101/2022.01.25.22269839'}, { 'key': 'ref=5', 'doi-asserted-by': 'crossref', 'unstructured': 'Qin LH, Kong L, Shi GJ, Wang ZT, Ge BX. Andrographolide inhibits the ' 'production of TNF-α and interleukin-12 in lipopolysaccharide-stimulated ' 'macrophages: Role of mitogen-activated protein kinases. Biol Pharm Bull. ' '2006; 29: 220-224.', 'DOI': '10.1248/bpb.29.220'}, { 'key': 'ref=6', 'unstructured': 'Akbar S. Andrographis paniculata: A review of pharmacological activities ' 'and clinical effects. Altern Med Rev. 2011; 16: 66-77.'}, { 'key': 'ref=7', 'doi-asserted-by': 'crossref', 'unstructured': 'Nguyen HT, Do VM, Phan TT, Nguyen Huynh DT. The potential of ' 'ameliorating COVID-19 and sequelae from andrographis paniculata via ' 'bioinformatics. 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