Coronavirus disease 2019 (COVID-19) is an extremely contagious viral infection caused by the SARS-CoV-2 virus, which results in severe acute respiratory syndrome. It has had a catastrophic effect on the demography of the globe. It is now the most crucial aspect of global health. In late December 2019, the first cases of this predominantly respiratory viral illness were reported in Wuhan, Hubei Province, China. SARS-CoV-2 rapidly spread across the globe. On March 11, 2020, the World Health Organization (WHO) had to declare it as a global pandemic.
The 150 COVID-19 non-hospitalized patients in the current trial, which is a three-arm randomized interventional study, ranged in severity from mild to moderate. The participants were randomly assigned to receive the standard treatment protocol alone, the standard treatment protocol plus colchicine, or the standard treatment protocol plus probiotics.
The study's findings regarding the sociodemographic characteristics of the participants show that approximately one third (34.7%) of them are between the ages of 29 and 39 years, one-quarter (24.7%) are between the ages of 18 and 28 years, and forty percent (40.6%) are over the age of 40 years. Of the 150 participants, 84% were female and 66% were male, which is consistent with Doerre and Doblhammer (15) finding that infection rates are highest among the young and Sex ratios show that women at working ages have greater infection risks than males.
In addition, the smoking rate among study participants was 23% which is comparable to that of Farsalinos et al. (16), who discovered that hospitalized COVID-19 patients had a smoking prevalence that was roughly one-fourth of what was predicted.
Notably, there is no statistically significant difference in the sociodemographic features of the three groups, suggesting good matching.
In line with Hakki et al. (17) who found that peak RNA viral load and peak infectious viral load occurred a median of 3 days after symptom onset, the current study revealed that the average duration of symptom onset is the fourth day. As a result, the majority of the study participants sought medical attention at the peak of symptom onset.
Further subgroup analysis revealed that the mean duration of symptoms improvement after intervention is 9.8 days in mild cases and 13 days in moderate cases, with a statistically significant difference between them, which is consistent with Faiq et al. (19) who found the median survival time was 12 days in moderate hospitalized patients. The mean duration of symptoms improvement after intervention is 12 days, and there is no statistically significant difference between the three groups.
Tardif et al. and Dorward et al. (20) trials, which were conducted on 4,488 and 4,997 non-hospitalized participants while Recovery (21) trial were carried out on 19,423 hospitalized participants, found no statistically significant difference between the colchicine and usual care protocol for time of improvement and hospitalizations in the group treated with the standard protocol and colchicine.
The results of the current study, however, did not agree with a meta-analysis conducted by Hariyanto et al. (22) who sought to investigate the impact of colchicine as a treatment option for COVID-19 on January 29, 2021. It was revealed that a total of eight studies involving 5778 COVID-19 patients were included in this meta-analysis. Colchicine treatment was linked to better COVID-19 results.
Abdelfattah et al. (23) conducted a retrospective study of 100 patients hospitalized at the Ain Shams University Field Hospital and concluded that colchicine has a significant effect on the participants in terms of duration of symptom improvement and hospitalization.
However, additional clinical trials are required to validate the findings, as they are based on observational studies.
The current study found that 44% of the colchicine group participants experienced gastrointestinal adverse events, particularly at the beginning of the regimen on dose 0.5 mg three times per day for three days, then twice daily for four days. This is consistent with Terkeltaub et al. (24) and Robert et al. (24) studies, which found that 36.5% of participants who took colchicine developed diarrhea.
In addition to clinical improvement, the recent trial evaluated the alternation in hematological parameters of individuals with mild to moderate severity before and after the intervention which was statistically significant and indicates that CBC, CRP, ferritin, and D-dimer may be employed as prognostic and follow-up tools for both disease severity and outcomes. which agrees with Yasmin et al. meta-analysis of five RCTs concluded that CRP and D-dimer levels are crucial in determining the severity of COVID-19 because elevated levels are linked to a poor prognosis. Other studies have also used these parameters to monitor disease severity and outcomes. (25)
Additionally, Qin et al. (26) study revealed that lymphopenia, the most well-known hematological abnormality in patients affected by COVID-19 infection, is seen in up to 85% of severe cases with the severity of lymphopenia linked to outcome. Soraya et al.'s (27) study revealed that leukocytes and neutrophils were significantly higher in severe than in non-severe COVID-19 infected patients. Leukocyte and neutrophil counts also increased as the COVID-19 disease progressed in the severe groups, which is in line with the findings of our study, which show that there is a statistically significant difference between mild and moderate cases with regard to CBC parameters (neutrophils and lymphocytes levels).
Further subgroup analysis revealed no statistically significant difference in inflammatory biomarker levels between the colchicine group and controls, and these results concur with those of Deftereos et al. (28) who found no significant differences in CRP level between the control and colchicine groups.
As opposed to Sarwar et al. (29) who reported from a meta-analysis of six RCTs that Colchicine is effective in decreasing inflammatory biomarkers seen in moderate-to-severe COVID-19 patients. According to Sandhu et al. (30), patients in the colchicine group also had a more pronounced decline in the inflammatory markers ferritin (P = 0.012), D-dimer (P = 0.037), and CRP.
On the other hand, the group that received probiotics and the standard of care of treatment shows no statistically significant difference from the controls regarding the time of improvement and for hospitalizations due to COVID-19. In addition, there is no statistically significant difference between the two groups with regard to of biochemical outcomes, which opposes Wischmeyer et al. (31) who claimed that LGG is well-tolerated and is associated with a longer time to COVID-19 development.
The majority of clinical trials on the use of probiotics during COVID-19 use small sample sizes. Most of them have relied on subjective conclusions. In addition, there has been considerable variation among these studies. Most of the studies and meta-analyses were limited to healthy young adults and excluded the elderly as this population is frequently polymedicated and frequently has multiple comorbidities. Additional clinical trials are required to adequately validate this conclusion. (32).