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In one of the first reported cases of its kind, a 3-week-old infant in critical condition recovered from COVID-19 due to rapid recognition and treatment by physicians from McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth). The case was published April 22 in the New England Journal of Medicine.

As more data is released on COVID-19, the original belief that pediatric patients are spared from the worst of the disease has been disproven.

"We are still so early in the research and data available on COVID-19, and as providers, we need to be aware that children can get critically ill from this virus," said Alvaro Coronado Munoz, MD, first author and assistant professor of pediatric critical care medicine at McGovern Medical School at UTHealth. "It's important for parents to understand that they should not delay seeking care for their children if there's any presence of fever or trouble breathing."

The child first presented at a local hospital with nasal congestion, rapid breathing, and reduced eating. Physicians there recorded a temperature of 97.0 degrees, high pulse rate, and low oxygen saturation. The child was transferred to a pediatric intensive care unit, and Coronado and other team members were alerted. Upon arrival, the child had low blood pressure and hypothermia, as well as continued rapid heart rate and breathing. Lung X-rays revealed opacity and collapse in one of the upper lobes, indications of pneumonia.

As it was early in the pandemic, it would take a week for test results from a nasal swab to return as positive for the coronavirus, but physicians did not wait before moving into a COVID-19 action plan for the pediatric intensive care unit (PICU).

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Prophylaxis

While there is very limited data (and none specific for COVID-19), the following "cocktail" may have a role in the prevention/mitigation of COVID-19 disease. While there is no high-level evidence that this cocktail is effective; it is cheap, safe and widely available.

Vitamin C 500 mg BID and Quercetin 250-500 mg BID [1 -5] Zinc 75-100 mg/day (acetate, gluconate or picolinate). Zinc lozenges are preferred. After 1 month, reduce the dose to 30-50 mg/day. [1,6-9]

Melatonin (slow release): Begin with 0.3mg and increase as tolerated to 2 mg at night [10-13]

Vitamin D3 1000-4000 u/day [14-20]Optional: Famotidine 20-40mg/day [21]

Optional/uncertain: Once weekly chloroquine/hydroxychloroquine may have a role in prophylaxis in high risk subgroups i.e. heath care workers, residents of nursing homes, etc. Ongoing studies are testing this hypothesis.



Symptomatic patients (at home):

Vitamin C 500 mg BID and Quercetin 250-500 mg BID Zinc 75-100 mg/day

Melatonin 6-12 mg at night (the optimal dose is unknown)Vitamin D3 2000-4000 u/day

Optional: ASA 81 -325 mg/day

Optional: Famotidine 20-40mg/day

Optional: Hydroxychloroquine 400mg BID day 1 followed by 200mg BID for 4 days [22]. Recent evidence suggests that HCQ has no role in the treatment of COVID-19 in hospitalized patients.[23] However, the potential role of HCQ in early symptomatic patients (prior to hospitalization) is unknown.

Optional: Ivermectin 150-200 ug/kg (single dose) [24,25]

In symptomatic patients, monitoring with home pulse oximetry is recommended. Ambulatory desaturation < 94% should prompt hospital admission



Mildly Symptomatic patients (on floor):

Vitamin C 500 mg q 6 hourly and Quercetin 250-500 mg BID (if available)

Zinc 75-100 mg/day

Melatonin 6-12 mg at night (the optimal dose is unknown)

Vitamin D3 2000-4000 u/day

Enoxaparin 60 mg daily [26-30]

Methylprednisolone 40 mg q 12 hourly ; increase to 80 mg q 12 hourly in patients with progressive symptoms and increasing CRP. [31-35]

Famotidine 40mg daily (20 mg in renal impairment)

Optional: Remdesivir,200 mg IV loading dose D1, followed by 100mg day IV for 9 days. [36,37]This agent has been reported to reduce time to recovery (based on an ordinal scale). [37] The benefit of this agent on patient centered outcomes is unclear.

Optional: Ivermectin 150-200 ug/kg (single dose)

N/C 2L /min if required (max 4 L/min; consider early t/f to ICU for escalation of care).

Avoid Nebulization and Respiratory treatments. Use "Spinhaler" or MDI and spacer if required.

Avoid CPAP or BiPAP

T/f EARLY to the ICU for increasing respiratory signs/symptoms and arterial desaturation.



Respiratory symptoms (SOB; hypoxia- requiring N/C 4 L min: admit to ICU): Essential Treatment (dampening the STORM)

1.Methylprednisolone 80 mg loading dose then 40mg q 12 hourly for at least 7 days and until transferred out of ICU. In patients with an increasing CRP or worsening clinical status increase the dose to 80 mg q 12 hourly, then titrate down as appropriate. [31-35]

2.Ascorbic acid (Vitamin C) 3g IV q 6 hourly for at least 7 days and/or until transferred out of ICU. Note caution with POC glucose testing (see below). [38-46]

3.Full anticoagulation: Unless contraindicated we suggest FULL anticoagulation (on admission to the ICU) with enoxaparin, i.e 1 mg kg s/c q 12 hourly (dose adjust with Cr Cl < 30mls/min). [26-30]Heparin is suggested with CrCl < 15 ml/min. Alternative approach: Half-dose rTPA: 25mg of tPA over 2 hours followed by a 25mg tPA infusion administered over the subsequent 22 hours, with a dose not to exceed 0.9 mg/kg followed by full anticoagulation.

Note: A falling SaO2 despite respiratory symptoms should be a trigger to start anti-inflammatory treatment (see Figure 2).
Note: Early termination of ascorbic acid and corticosteroids will likely result in a rebound effect with clinical deterioration (see Figure 3).


Additional Treatment Components (the Full Monty)



4.Melatonin 6-12 mg at night (the optimal dose is unknown).



5.Famotidine 40mg daily (20 mg in renal impairment)



6.Vitamin D 2000-4000 u PO daily



7.Thiamine 200 mg IV q 12 hourly



8.Magnesium: 2 g stat IV. Keep Mg between 2.0 and 2.4 mmol/l. Prevent hypomagnesemia (which increases the cytokine storm and prolongs Qtc). [47-49]



9.Optional: Azithromycin 500 mg day 1 then 250 mg for 4 days (has immunomodulating properties including downregulating IL-6; in addition, Rx of concomitant bacterial pneumonia). [50]



10.Optional: Simvastatin 80 mg/day. Of theoretical but unproven benefit. Simvastatin has been demonstrated to reduce mortality in the hyper-inflammatory ARDS phenotype. [51] Statins have pleotropic anti-inflammatory, immunomodulatory, antibacterial and antiviral effects. In addition, statins decrease expression of PAI-1.



11.Optional: Remdesivir. The role of this agent in patients with more advanced pulmonary involvement appears to be limited.



12.Broad-spectrum antibiotics if superadded bacterial pneumonia is suspected based on procalcitonin levels and resp. culture (no bronchoscopy). Due to the paradox of hyper-inflammation and immune suppression (a major decrease of HLA-DR on CD14 monocytes) secondary bacterial infection is not uncommon.



13.Maintain EUVOLEMIA (this is not non-cardiogenic pulmonary edema). Due to the prolonged "symptomatic phase" with flu-like symptoms (6-8 days) patients may be volume depleted. Cautious rehydration with 500 ml boluses of Lactate Ringers may be warranted, ideally guided by non-invasive hemodynamic monitoring. Diuretics should be avoided unless the patient has obvious intravascular volume overload. Avoid hypovolemia.



14.Early norepinephrine for hypotension.



15.Escalation of respiratory support (steps); Try to avoid intubation if at all possible, (see Figure 4)

Accept "permissive hypoxemia" (keep O2 Saturation > 84%); follow venous lactate and Central Venous O2 saturations (ScvO2) in patents with low arterial O2 saturations
N/C 1-6 L/min
High Flow Nasal canula (HFNC) up to 60-80 L/min
Trial of inhaled Flolan (epoprostenol)
Attempt proning (cooperative repositioning-proning)
Intubation ... by Expert intubator; Rapid sequence. No Bagging; Full PPE. Crash/emergency intubations should be avoided.
Volume protective ventilation; Lowest driving pressure and lowest PEEP as possible. Keep driving pressures < 15 cmH2O.
Moderate sedation to prevent self-extubation
Trial of inhaled Flolan (epoprostenol)
Prone positioning.

There is widespread concern that using HFNC could increase the risk of viral transmission. There is however, no evidence to support this fear. HFNC is a better option for the patient and the health care system than intubation and mechanical ventilation. CPAP/BiPAP may be used in select patients, notably those with COPD exacerbation or heart failure. A sub-group of patients with COVID-19 deteriorates very rapidly. Intubation and mechanical ventilation may be required in these patients



16. Salvage Treatments

Plasma exchange [52-54]. Should be considered in patients with progressive oxygenation failure despite corticosteroid therapy. Patients may require up to 5 exchanges.
High dose corticosteroids; 120mg methylprednisolone q 6-8 hourly
Siltuximab and Tocilizumab (IL-6 inhibitors) [55,56]
Convalescent serum; the role and timing of convalescent serum are uncertain. [57-59]
CVVH with cytokine absorbing/filtering filters [60]
?? ECMO < 60 yrs. and no severe commodities/organ failure [61]. Unlike "typical ARDS" patients do not progress into a resolution phase. Rather, patients with COVID-19 progress to a severe fibro-proliferative phase and ventilator dependency. ECMO is these patients would serve very little purpose.



17.Treatment of Macro****e Activation Syndrome (MAS)

A sub-group of patients will develop MAS. This appears to be driven by SARS-CoV-2 induced inflammasome activation and increased IL-1 production (see Figure 5). [62,63]
A ferritin > 4400 ng/ml is considered diagnostic of MAS. Other diagnostic features include increasing AST/ALT and increasing CRP. [64]
"High dose corticosteroids." Methylprednisolone 120 mg q 6-8 hourly for at least 3 days, then wean according to Ferritin, CRP, AST/ALT (see Figure 6). Ferritin should decrease by at least 15% before weaning corticosteroids.
Consider plasma exchange.
Anakinra (competitively inhibits IL-1 binding to the interleukin-1 type I receptor) can be considered in treatment failures.



18.Monitoring

Daily: PCT, CRP, IL-6, BNP, Troponins, Ferritin, Neutrophil-Lymphocyte ratio, D-dimer and Mg. CRP, IL-6 and Ferritin track disease severity closely (although ferritin tends to lag behind CRP). Early CRP levels are closely associated with the degree of pulmonary involvement and the CT score. [65] Thromboelastogram (TEG) on admission and repeated as indicated.
In patients receiving IV vitamin C, the Accu-Chek POC glucose monitor will result in spuriously high blood glucose values. Therefore, a laboratory glucose is recommended to confirm the blood glucose levels.
Monitor QTc interval if using chloroquine/hydrochloroquine and azithromycin and monitor Mg++ (torsades is uncommon in monitored ICU patients)
No routine CT scans, follow CXR and chest ultrasound.
Follow ECHO closely; Pts develop a severe cardiomyopathy.



19.Post ICU management

a.Enoxaparin 40-60 mg s/c daily
b.Methylprednisolone 40 mg day, then wean slowly
c.Vitamin C 500 mg PO BID
d.Melatonin 3-6 mg at night

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"Every patient I've prescribed it to has been very, very ill and within 8 to 12 hours, they were basically symptom-free," Cardillo told Eyewitness News. "So clinically I am seeing a resolution."

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Kelly tells WENY News plenty of personal research and discussions with his doctor guided his decision to take hydroxychloroquine.

"He said 'okay, I can't tell you you're right and I can't tell you you're wrong'," Kelly recalled of the conversation between he and his doctor. "'I can just tell you that you've looked at it pretty strongly and I would concur with you that your general state of health, you're a pretty good candidate for this.' So, I started taking it."

The prescription was relatively short.

"A total of nine pills, ten pills, one each day for that," Kelly said.

Kelly was diagnosed with COVID-19 two months ago on March 27 after he was tested at a drive-thru clinic in Butler, Pa. The 72-year-old was quarantined in his Butler home for over a month, and was officially considered coronavirus-free on May 6. He is now participating in a national clinical trial studying the effectiveness of blood transfusion for treating COVID-19.

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A prestigious medical journal is criticizing news media coverage of hydroxychlorioquine in the battle against coronavirus, saying there is evidence the anti-malarial drug combined with the antibiotic azithromycin helps in the early stages of outpatient treatment.


"These medications need to be widely available and promoted immediately for physicians to prescribe," the American Journal of Epidemiology reported in an article published this week that pushed back against claims the regimen has been dangerous or ineffective in all cases.

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Dr. Gregg DeNicola is one of the first doctors in Southern California to develop a cohesive treatment plan for COVID-19 that includes the widely debated drug hydroxychloroquineand he told The Epoch Times he's seen only positive results.

"A couple [patients] look you in the eye and say, 'I think I'm going to die,'" DeNicola said. But none of the Laguna Beach-based doctor's 95 COVID-19 patients have died yet, and he credits hydroxychloroquine with helping to save them.

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Chief doctor Nurettin Yiyit - whose art work is on the hospital walls - says it's key to use hydroxychloroquine early. "Other countries are using this drug too late," he says, "especially the United States. We only use it at the beginning. We have no hesitation about this drug. We believe it's effective because we get the results."

On a tour of the hospital, adding and subtracting protective layers as we go, he explains that Turkey's approach is to "get ahead of the virus", by treating early and treating aggressively. They use hydroxychloroquine and other drugs, along with blood plasma and oxygen in high concentrations.

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Speaking further, Bright observed that there were 100 percent positive outcome and zero deaths with 4Aminoquinolines in COVID-19 Response, stressing that quinine works in an advanced stage of COVID-19 as the case of the single laboratory tested positive clients have shown. "Although it has been proven that CQ/HCQ is effective in early COVID-19, more studies will be needed due to the small sample size deployed while quinine is effective in the advanced stage of COVID-19 including ICU "However, post-treatment intermittent prophylaxis is recommended in COVID-19. This is why mentioned earlier that more studies are needed," she said.


According to her, the LWI Study Protocols for COVID-19 Response is affordable, scalable, and replicable for all Africans and in the Diaspora. "Recently it was discovered that some tertiary health institutions are using the LWI Study Protocols for COVID-19 Prophylaxis and Outpatient Care. The reason is obvious. "Chloroquine / Hydroxychloroquine has multiple modes of action which prevents the virus from penetrating the host cell using its S protein and Protease. It breaks the polymerase chain and prevents viral replication. "It is a zinc ionophore and ensures penetration of zinc into the viral cell." She added.

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"Tucker, I want to tell you about a 96-year-old man in Florida who said one night, 'I don't think I'm going to make it. I feel very weak. The end is coming. I'm coughing, I'm short of breath, I can't get up from the couch,'" Siegel recounted. "The next day he was on hydroxychloroquine and antibiotics, per his cardiologist, he got up the next day, he was fine."


"This man is my father, Tucker," Siegel said.


"Wow," Carlson responded. "That couldn't be a clearer and heavier example."

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The key note of this preprinted study, according to CrowdProtocol doctors, is the early treatment of COVID-19 in outpatients before they require hospitalization for a severe COVID-19 case, the latter of which was used to suggest no benefit to HCQ use in hospitalized patients.


"What differentiates this study is that patients were diagnosed very early with COVID-19 in an outpatient setting and treated early on," co-author of the study, Alexion Pharma Germany Dr. Roland Derwand said in a statement provided to Newsmax. Dr. Derwand worked the study with Dr. Martin Scholz and Dr. Vladimir Zelenko of Lenox Hill Hospital in Monroe, N.Y.


"Unfortunately, we seem to have forgotten that it is common medical knowledge to treat any patient with a disease as soon as possible. Dr. Zelenko treated his patients immediately with the three drugs to increase effects and didn't wait for the disease to develop."


A news release of the study declares hospitalization of 141 high-risk patients who were treated was 84% less likely than the untreated group. Just one patient died in the treated group vs. 13 patients that died from the untreated group.


"At this point, the media has left us with a grim view of anything related to hydroxychloroquine, but that is why studies like this are so important," Dr. Zelenko said in a statement.

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Today the Association of American Physicians & Surgeons filed its motion for a preliminary injunction to compel release to the public of hydroxychloroquine by the Food & Drug Administration (FDA) and the Department of Health & Human Services (HHS), in AAPS v. HHS, No. 1:20-cv-00493-RJJ-SJB (W.D. Mich.). Nearly 100 million doses of hydroxychloroquine (HCQ) were donated to these agencies, and yet they have not released virtually any of it to the public.

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