Therapies to Prevent Progression of COVID-19

Written by National Institutes for Health on February 17, 2022. Posted in Current News

COVID-19 is a global pandemic. Treatment with hydroxychloroquine (HCQ), zinc, and azithromycin (AZM), also known as the Zelenko protocol, and treatment with intravenous (IV) vitamin C (IVC) have shown encouraging results in a large number of trials worldwide.

In addition, vitamin D levels are an important indicator of the severity of symptoms in patients with COVID-19.

Objectives

Our multicenter, randomized, open-label study aimed to assess the effectiveness of HCQ, AZM, and zinc with or without IVC in hospitalized patients with COVID-19 in reducing symptom severity and duration and preventing death.

Methods

Hospitalized patients with COVID-19 in seven participating hospitals in Turkey were screened for eligibility and randomly allocated to receive either HCQ, AZM, and zinc (group 1) or HCQ, AZM, zinc plus IV vitamin C treatment (group 2) for 14 days. The patients also received nontherapeutic levels of vitamin D3.

The trial is registered on the Australian and New Zealand Clinical Trial Registry ACTRN12620000557932 and has been approved by the Australian Therapeutic Goods Administration (TGA).

Results

A total of 237 hospitalized patients with COVID-19 aged 22-99 years (mean: 63.3 ± 15.7 years) were enrolled in the study. Almost all patients were vitamin D deficient (97 percent), 55 percent were severely vitamin D deficient (<25 nmol/L) and 42 percent were vitamin D deficient (<50 nmol/L); three percent had insufficient vitamin D levels (<75 nmol/L), and none had optimal vitamin D levels.

Of the patients, 73 percent had comorbidities, including diabetes (35 percent), heart disease (36 percent), and lung disease (34 percent).

All but one patient (99.6 percent; n = 236/237) treated with HCQ, AZM, and zinc with or without high-dose IV vitamin C (IVC) fully recovered. Additional IVC therapy contributed significantly to a quicker recovery (15 days versus 45 days until discharge; p = 0.0069).

Side effects such as diarrhea, nausea, and vomiting, reported by 15-27 percent of the patients, were mild to moderate and transient. No cardiac side effects were observed.

Low vitamin D levels were significantly correlated with a higher probability of admission to the intensive care unit (ICU) and longer hospital stay.

Sadly, one 70-year-old female patient with heart and lung disease died after 17 days in ICU and 22 days in the hospital. Her vitamin D level was 6 nmol/L on admission (i.e., severely deficient).

Conclusions

Our study suggests that the treatment protocol of HCQ, AZM, and zinc with or without vitamin C is safe and effective in the treatment of COVID-19, with high dose IV vitamin C leading to a significantly quicker recovery.

Importantly, our study confirms vitamin D deficiency to be a high-risk factor of severe COVID-19 disease and hospitalization, with 97 percent of our study’s patient cohort being vitamin D deficient, 55 percent of these being severely vitamin D deficient, and none had optimal levels.

Future trials are warranted to evaluate the treatment with a combination of high-dose vitamin D3 in addition to HCQ, AZM, and zinc and high-dose intravenous vitamin C.

Our study suggests that the combination of hydroxychloroquine (HCQ), azithromycin (AZM), and zinc with or without IV vitamin C is safe and effective in the early treatment of COVID-19. No cardiac side effects were observed.

All but one patient (99.6 percent; n = 236/237) in our trial fully recovered, with IV vitamin C contributing to a significantly quicker recovery (15 days versus 45 days until discharge).

Our study’s findings are in line with the international literature, whereby the treatment of COVID-19 with HCQ, zinc, and AZM or intravenous vitamin C has shown to be effective in aiding recovery and reducing mortality.

The effectiveness of HCQ with or without AZM in the treatment of COVID-19 has been demonstrated in a meta-analysis of more than 290 trials involving more than 412,000 patients, whereby improvement of symptoms and prevention of death were achieved at 64-75 percent if treatment was provided early [6].

The combination of HCQ, AZM, and zinc, also known as the Zelenko protocol, has been shown to reduce hospitalization and mortality significantly, whereby a significantly smaller number of patients in the treatment group was hospitalized or died compared with the untreated group (hospitalized: three percent treated versus 15 percent untreated; died: 0.7 percent treated versus 3.4 percent untreated) [2].

To date, few studies have looked into the effectiveness of early treatment of patients with COVID-19 with vitamin C/ascorbic acid [22]. One study found that high-dose intravenous vitamin C provided a 72 percent improvement in symptoms and reduced recovery time [17]. In contrast, a study that used an oral combination of vitamin C and zinc did not find a significant difference in the improvement of symptoms between the treatment and the control group [23].

Our study is the first to combine HCQ, AZM, and zinc with high-dose intravenous vitamin C therapy, resulting in the total recovery of 99.6 percent of participants, whereby IVC contributed to a significantly quicker recovery and discharge from the hospital. The treatment protocol was highly tolerable and did not cause any cardiac complications.

Importantly, our study confirmed vitamin D deficiency to be a high-risk factor of severe COVID-19 disease and hospitalization, with 97 percent of our study’s patient cohort being vitamin D deficient, of which 55 percent were severely vitamin D deficient.

This finding is in line with the international literature, highlighting the importance of adequate vitamin D levels for immune function, prevention of acute respiratory infections including COVID-19, and recovery [18,19,24,25].

Specifically, vitamin D protects against pathogens including viruses via the innate and adaptive immune system, involving white blood cells and T-cells [21].

Several studies conducted earlier in the pandemic have linked vitamin D deficiency with the risk and severity of COVID-19 infection and hospitalization [26,27], while a recent systematic review and meta-analysis of eight studies and >1500 participants concluded that vitamin D levels over 50 nmol/L can reduce the mortality risk of COVID-19 to zero [28].

It is known that a large proportion of Australians are vitamin D deficient [29]. Research has proven vitamin D supplementation to be a key factor to alleviate vitamin D deficiency and subsequently to prevent the onset and severity of acute respiratory tract infections and reduce morbidity and mortality [20].

Higher daily doses of 5000-10000 IU vitamin D3 orally are considered safe and effective in elevating vitamin D deficiency [19].

Furthermore, our study revealed that lower vitamin D levels were significantly correlated with a higher probability of being admitted to the ICU, leading to a significantly longer hospital stay.

While comorbidities contribute to the risk of hospitalization [30] (three-quarters of our study population had comorbidities), severe vitamin D deficiency (6 nmol/L) was the most probable cause for the death of the 70-year-old patient with lung and heart disease.

In summary, our study found vitamin D deficiency to be a high-risk factor for severe COVID-19 disease and hospitalization, with 97 percent of our study’s patient cohort being vitamin D deficient, of which 55 percent were severely vitamin D deficient, and none had optimal levels. In addition, vitamin D levels were significantly correlated to ICU admission and longer hospital stay.

Furthermore, our study contributes to the evidence of HCQ, AZM, and zinc with or without IV vitamin C being safe and effective in the treatment of COVID-19, with IV vitamin C contributing to a significantly quicker recovery.

Future research based on the findings in stage 1 of our trial in line with the international literature of the importance of adequate vitamin D levels to immune function and recovery are encouraged to adapt the protocol for the next stage of the trial by adding a high-dose vitamin D3 to all enrolled patients.

See more here: ncbi.nlm.nih.gov

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