Phase II, open label, randomized controlled trial to evaluate safety and efficacy of ACT 12 tablet and ACT 13 dry syrup as an immunomodulator in adult Covid 19 positive patients

In the present study, Gplife Healthcare Private Limited’sACT-12 and ACT-13, nutraceutical formulations developed using advancedphytochemistry, were compared for its safety and clinical efficacy along withstandard of care in Hospitalized COVID 19 patients. The interpretation of thestudy parameters obtained is expressed as follows.

60.0% of cases from Test Group i.e. ACT-12 andACT-13 along with standard of care showed PCR Negativity at Day 4 comparedto 40% from the standard of care group.

76.66% of cases from Test Group i.e. ACT-12 andACT-13 along with standard of care showed PCR Negativity at day 7 comparedto 60% from the standard of care group.

No Patient continued to remain positive after the 10th dayin the Test Group i.e. ACT-12 and ACT-13 along with standard of care, whereasin the standard care group 7 patients (23.3 %) were positive after 10 days.

Test group i.e. ACT-12 and ACT-13 along with standard ofcare showed substantial improvement in SpO2.

The average respiratory rate showed improvement afteraddition of ACT-12 and ACT-13 in standard of care and also subjects in samegroup were relieved of cough, shortness of breath, fever and Body ache, fasterthan subjects on only standard of care. It can be inferred that ACT-12 andACT-13 contributed to improve disease-specific symptoms and overall quality oflife of subject.

ACT-12 and ACT-13 demonstrated anti-inflammatory activity bylowering CRP and LDH levels thereby reducing risk of lung tissue injury &lung fibrosis.

Thrombocytopenia is associated with increased risk of severedisease and mortality in patients with COVID-19; it was found that there wasimprovement in Thrombocytopenia in group where ACT-12 and ACT-13 was added instandard of care which can reduce risk of hospitalization.

The IgG and IgM immunoglobulin levels were raised insubjects treated with ACT-12 and ACT-13 along with standard of care which canbe related to improved antibody functionality and thereby the immunomodulatoryactivity offered.

In subjects treated with ACT-12 and ACT-13 along withstandard of care, it was found improvement in fluctuated hematologicalparameters. No significant post treatment change in any of the biochemicalinvestigations like liver function, kidney function, and lipid profiles. Nofluctuation found in respiratory rate and blood pressure. This indicates safetyof the ACT-12 and ACT-13 in management of COVID 19.

No mortality has been observed in the TEST group (ACT-12 andACT-13 along with standard of care) throughout the study and hence thisdemonstrates safety of the treatment. No Patient was positive after the 10thday in the same group.

There is consensus that in severe COVID-19 infections, anexacerbated pulmonary and systemic inflammatory response occurs, with increasedserum levels of inflammatory markers such as C-reactive protein (CRP) andlactic dehydrogenase (LDH), all of which may result in cytokine storms similarto SARS and MERS. In present clinical study there is reduction in parameterslike CRP and LDH with quick recovery time which may lead to better managementof the cytokine storm due to ACT-12 and ACT-13 addition in standard of care.

Around 13.3 % CORONA positive casesin group of ACT-12 and ACT-13 along with standard of care reported withdiabetes and hypertension completely recovered without any other complications.