Abstract
BackgroundCOVID19 is a high burden for medicine and society as still no specific therapy exists. Most patients depend on symptomatic treatment, comparable to the symptomatic treatment in common respiratory infection e.g., Acetaminophen or Ibuprofen. Many cases of COVID19 show mild forms without need of hospitalization. In this randomized, open-label, multicentre, comparative trial we analysed the efficacy, safety, and tolerability of the herbal medicinal product BNO 1030 in mild cases of COVID-19 to offer an additional symptomatic relive.MethodsThe study was designed as an open label randomized, prospective, multicentred clinical trial. Out of 133 screened outpatients aged 18 to 70 with mild COVID-19 symptoms 120 patients were randomised (1:1) in 2 parallel groups. The main group received BNO 1030 in addition to symptomatic therapy (acetaminophen or ibuprofen). The control group got a symptomatic therapy only. The patients with laboratory proven COVID 19 were included for the final analyses: 47 – in the main group and 46 – in the control one. The evaluation criteria were dynamics of the symptoms: hyperthermia, myalgia, nasal congestion, nasal discharge, coughing, anosmia, rhinolalia, sore throat, duration of the use of antipyretics (clinically significant fever). These symptoms were assessed during the physician’s visit on a 4-point scale (0 — absent, 1 — insignificant, 2 — moderate, 3 — strong/pronounced) and self- assessed via ten-point visual analogue scale (VAS) daily in a patient’s diary. The primary endpoint was the decrease of the average score compared to the baseline defined as “therapeutic benefit” from the usage of BNO 1030.ResultsIn the comparison of both groups over the treatment time, the main group (n = 47) showed a greater decrease in the severity of symptoms of fever, myalgia, nasal congestion, coughing, anosmia and rhinolalia, assessed by the doctor on a 4-point scale on V2 (4th day) and V3 (14th day) compared to those on V1, as well as a reduction of the antipyretics intake duration (p < 0.05). Significant differences of the main group were obtained, too, based on the results of symptoms self-assessment by the patient. The “therapeutic benefit from the use of BNO 1030 was 3 days. There is an increase in the number of recovered patients from 73.9–96.6 % according to the average symptom score, and a decrease in the number of hospitalized patients from 8.6–4.4 % in the main group., as compared to the data of the control group (p < 0.05). All patients tolerated the herbal medicine well, with no adverse drug reactions being reported.ConclusionsBNO 1030 (Imupret®) offers a safe and effective treatment benefit in patients with mild forms of diagnosed COVID-19 aged 18–70 in addition to symptomatic treatment with acetaminophen or NSAIDs. COVID 19 positive patients treated with Imupret showed an earlier relive of symptoms when being treated with BNO 1030.Trial registrationThis trial was registered in ClinicalTrial.gov: NCT04797936.
Highlights
For patients with mild COVID-19, who are not included in the risk factor groups, WHO and national guidelines recommend outpatient treatment in compliance with the self-isolation regimen
As less attention is paid to mild course cases, current data show that 40–80 % of patients diagnosed with COVID-19 feature a mild course of the disease [8, 9], this trial elucidates the potential of herbal medicinal products with a proven safety as an optimization of the symptomatic treatment for mild COVID 19 cases
This study aimed at evaluating the efficacy of the BNO 1030 herbal extract (Imupret®) as an additional therapy to standard treatment compared to that of the standard symptomatic therapy alone for mild COVID-19 according to the WHO and national guidelines [1, 2]
Summary
For patients with mild COVID-19, who are not included in the risk factor groups, WHO and national guidelines recommend outpatient treatment in compliance with the self-isolation regimen. The mechanisms of potential medicinal products are associated with antiviral action (remdesivir, lopinavir, ritonavir, interferon beta), blockade of the virus fusion with the cell membrane — recombinant human angiotensinconverting enzyme, hydroxychloroquine, and some others, but they are considered for treatment of severe forms of the disease [17–19]. Some of these tested drugs did not show a clinical benefit [20–22]. Open-label, multicentre, comparative trial we analysed the efficacy, safety, and tolerability of the herbal medicinal product BNO 1030 in mild cases of COVID-19 to offer an additional symptomatic relive
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